[Congressional Record Volume 155, Number 196 (Sunday, December 20, 2009)]
[Senate]
[Pages S13628-S13637]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                           TEXT OF AMENDMENTS

                                 ______
                                 
  SA 3284. Mr. GREGG submitted an amendment intended to be proposed to 
amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       At the appropriate place, insert the following:

              TITLE __--HEALTHY MOTHERS AND HEALTHY BABIES

     SEC. _01. SHORT TITLE.

       This title may be cited as the ``Healthy Mothers and 
     Healthy Babies Access to Care Act''.

     SEC. _02. FINDINGS AND PURPOSE.

       (a) Findings.--
       (1) Effect on women's access to health services.--Congress 
     finds that--
       (A) the current civil justice system is eroding women's 
     access to obstetrical and gynecological services;
       (B) the American College of Obstetricians and Gynecologists 
     (ACOG) has identified nearly half of the States as having a 
     medical liability insurance crisis that is threatening access 
     to high-quality obstetrical and gynecological services;
       (C) because of the high cost of medical liability insurance 
     and the risk of being sued, one in seven obstetricians and 
     gynecologists have stopped practicing obstetrics and one in 
     five has decreased their number of high-risk obstetrics 
     patients; and
       (D) because of the lack of availability of obstetrical 
     services, women--
       (i) must travel longer distances and cross State lines to 
     find a doctor;
       (ii) have longer waiting periods (in some cases months) for 
     appointments;
       (iii) have shorter visits with their physicians once they 
     get appointments;
       (iv) have less access to maternal-fetal medicine 
     specialists, physicians with the most experience and training 
     in the care of women with high-risk pregnancies; and
       (v) have fewer hospitals with maternity wards where they 
     can deliver their child, potentially endangering the lives 
     and health of the woman and her unborn child.
       (2) Effect on interstate commerce.--Congress finds that the 
     health care and insurance industries are industries affecting 
     interstate commerce and the health care liability litigation 
     systems existing throughout the United States are activities 
     that affect interstate commerce by contributing to the high 
     costs of health care and premiums for health care liability 
     insurance purchased by health care system providers.
       (3) Effect on federal spending.--Congress finds that the 
     health care liability litigation systems existing throughout 
     the United States have a significant effect on the amount, 
     distribution, and use of Federal funds because of--
       (A) the large number of individuals who receive health care 
     benefits under programs operated or financed by the Federal 
     Government;
       (B) the large number of individuals who benefit because of 
     the exclusion from Federal taxes of the amounts spent to 
     provide them with health insurance benefits; and
       (C) the large number of health care providers who provide 
     items or services for which the Federal Government makes 
     payments.
       (b) Purpose.--It is the purpose of this title to implement 
     reasonable, comprehensive, and effective health care 
     liability reforms designed to--
       (1) improve the availability of health care services in 
     cases in which health care liability actions have been shown 
     to be a factor in the decreased availability of services;
       (2) reduce the incidence of ``defensive medicine'' and 
     lower the cost of health care liability insurance, all of 
     which contribute to the escalation of health care costs;
       (3) ensure that persons with meritorious health care injury 
     claims receive fair and adequate compensation, including 
     reasonable noneconomic damages;
       (4) improve the fairness and cost-effectiveness of our 
     current health care liability system to resolve disputes 
     over, and provide compensation for, health care liability by 
     reducing uncertainty in the amount of compensation provided 
     to injured individuals; and
       (5) provide an increased sharing of information in the 
     health care system which will reduce unintended injury and 
     improve patient care.

     SEC. _03. DEFINITIONS.

       In this title:
       (1) Alternative dispute resolution system; adr.--The term 
     ``alternative dispute resolution system'' or ``ADR'' means a 
     system that provides for the resolution of health care 
     lawsuits in a manner other than through a civil action 
     brought in a State or Federal court.
       (2) Claimant.--The term ``claimant'' means any person who 
     brings a health care lawsuit, including a person who asserts 
     or claims a right to legal or equitable contribution, 
     indemnity or subrogation, arising out of a health care 
     liability claim or action, and any person on whose behalf 
     such a claim is asserted or such an action is brought, 
     whether deceased, incompetent, or a minor.

[[Page S13629]]

       (3) Collateral source benefits.--The term ``collateral 
     source benefits'' means any amount paid or reasonably likely 
     to be paid in the future to or on behalf of the claimant, or 
     any service, product or other benefit provided or reasonably 
     likely to be provided in the future to or on behalf of the 
     claimant, as a result of the injury or wrongful death, 
     pursuant to--
       (A) any State or Federal health, sickness, income-
     disability, accident, or workers' compensation law;
       (B) any health, sickness, income-disability, or accident 
     insurance that provides health benefits or income-disability 
     coverage;
       (C) any contract or agreement of any group, organization, 
     partnership, or corporation to provide, pay for, or reimburse 
     the cost of medical, hospital, dental, or income disability 
     benefits; and
       (D) any other publicly or privately funded program.
       (4) Compensatory damages.--The term ``compensatory 
     damages'' means objectively verifiable monetary losses 
     incurred as a result of the provision of, use of, or payment 
     for (or failure to provide, use, or pay for) health care 
     services or medical products, such as past and future medical 
     expenses, loss of past and future earnings, cost of obtaining 
     domestic services, loss of employment, and loss of business 
     or employment opportunities, damages for physical and 
     emotional pain, suffering, inconvenience, physical 
     impairment, mental anguish, disfigurement, loss of enjoyment 
     of life, loss of society and companionship, loss of 
     consortium (other than loss of domestic service), hedonic 
     damages, injury to reputation, and all other nonpecuniary 
     losses of any kind or nature. Such term includes economic 
     damages and noneconomic damages, as such terms are defined in 
     this section.
       (5) Contingent fee.--The term ``contingent fee'' includes 
     all compensation to any person or persons which is payable 
     only if a recovery is effected on behalf of one or more 
     claimants.
       (6) Economic damages.--The term ``economic damages'' means 
     objectively verifiable monetary losses incurred as a result 
     of the provision of, use of, or payment for (or failure to 
     provide, use, or pay for) health care services or medical 
     products, such as past and future medical expenses, loss of 
     past and future earnings, cost of obtaining domestic 
     services, loss of employment, and loss of business or 
     employment opportunities.
       (7) Health care goods or services.--The term ``health care 
     goods or services'' means any obstetrical or gynecological 
     goods or services provided by a health care institution, 
     provider, or by any individual working under the supervision 
     of a health care provider, that relates to the diagnosis, 
     prevention, care, or treatment of any obstetrical or 
     gynecological-related human disease or impairment, or the 
     assessment of the health of human beings.
       (8) Health care institution.--The term ``health care 
     institution'' means any entity licensed under Federal or 
     State law to provide health care services (including but not 
     limited to ambulatory surgical centers, assisted living 
     facilities, emergency medical services providers, hospices, 
     hospitals and hospital systems, nursing homes, or other 
     entities licensed to provide such services).
       (9) Health care lawsuit.--The term ``health care lawsuit'' 
     means any health care liability claim concerning the 
     provision of obstetrical or gynecological goods or services 
     affecting interstate commerce, or any health care liability 
     action concerning the provision of (or the failure to 
     provide) obstetrical or gynecological goods or services 
     affecting interstate commerce, brought in a State or Federal 
     court or pursuant to an alternative dispute resolution 
     system, against a physician or other health care provider who 
     delivers obstetrical or gynecological services or a health 
     care institution (only with respect to obstetrical or 
     gynecological services) regardless of the theory of liability 
     on which the claim is based, or the number of claimants, 
     plaintiffs, defendants, or other parties, or the number of 
     claims or causes of action, in which the claimant alleges a 
     health care liability claim.
       (10) Health care liability action.--The term ``health care 
     liability action'' means a civil action brought in a State or 
     Federal Court or pursuant to an alternative dispute 
     resolution system, against a health care provider who 
     delivers obstetrical or gynecological services or a health 
     care institution (only with respect to obstetrical or 
     gynecological services) regardless of the theory of liability 
     on which the claim is based, or the number of plaintiffs, 
     defendants, or other parties, or the number of causes of 
     action, in which the claimant alleges a health care liability 
     claim.
       (11) Health care liability claim.--The term ``health care 
     liability claim'' means a demand by any person, whether or 
     not pursuant to ADR, against a health care provider who 
     delivers obstetrical or gynecological services or a health 
     care institution (only with respect to obstetrical or 
     gynecological services), including third-party claims, cross-
     claims, counter-claims, or contribution claims, which are 
     based upon the provision of, use of, or payment for (or the 
     failure to provide, use, or pay for) obstetrical or 
     gynecological services, regardless of the theory of liability 
     on which the claim is based, or the number of plaintiffs, 
     defendants, or other parties, or the number of causes of 
     action.
       (12) Health care provider.--
       (A) In general.--The term ``health care provider'' means 
     any person (including but not limited to a physician (as 
     defined by section 1861(r) of the Social Security Act (42 
     U.S.C. 1395x(r)), nurse, dentist, podiatrist, pharmacist, 
     chiropractor, or optometrist) required by State or Federal 
     law to be licensed, registered, or certified to provide 
     health care services, and being either so licensed, 
     registered, or certified, or exempted from such requirement 
     by other statute or regulation.
       (B) Treatment of certain professional associations.--For 
     purposes of this title, a professional association that is 
     organized under State law by an individual physician or group 
     of physicians, a partnership or limited liability partnership 
     formed by a group of physicians, a nonprofit health 
     corporation certified under State law, or a company formed by 
     a group of physicians under State law shall be treated as a 
     health care provider under subparagraph (A).
       (13) Malicious intent to injure.--The term ``malicious 
     intent to injure'' means intentionally causing or attempting 
     to cause physical injury other than providing health care 
     goods or services.
       (14) Noneconomic damages.--The term ``noneconomic damages'' 
     means damages for physical and emotional pain, suffering, 
     inconvenience, physical impairment, mental anguish, 
     disfigurement, loss of enjoyment of life, loss of society and 
     companionship, loss of consortium (other than loss of 
     domestic service), hedonic damages, injury to reputation, and 
     all other nonpecuniary losses of any kind or nature.
       (15) Obstetrical or gynecological services.--The term 
     ``obstetrical or gynecological services'' means services for 
     pre-natal care or labor and delivery, including the immediate 
     postpartum period (as determined in accordance with the 
     definition of postpartum used for purposes of title XIX of 
     the Social Security Act (42 U.S.C. 1396 et seq.)).
       (16) Punitive damages.--The term ``punitive damages'' means 
     damages awarded, for the purpose of punishment or deterrence, 
     and not solely for compensatory purposes, against a health 
     care provider who delivers obstetrical or gynecological 
     services or a health care institution. Punitive damages are 
     neither economic nor noneconomic damages.
       (17) Recovery.--The term ``recovery'' means the net sum 
     recovered after deducting any disbursements or costs incurred 
     in connection with prosecution or settlement of the claim, 
     including all costs paid or advanced by any person. Costs of 
     health care incurred by the plaintiff and the attorneys' 
     office overhead costs or charges for legal services are not 
     deductible disbursements or costs for such purpose.
       (18) State.--The term ``State'' means each of the several 
     States, the District of Columbia, the Commonwealth of Puerto 
     Rico, the Virgin Islands, Guam, American Samoa, the Northern 
     Mariana Islands, the Trust Territory of the Pacific Islands, 
     and any other territory or possession of the United States, 
     or any political subdivision thereof.

     SEC. _04. ENCOURAGING SPEEDY RESOLUTION OF CLAIMS.

       (a) In General.--Except as otherwise provided for in this 
     section, the time for the commencement of a health care 
     lawsuit shall be 3 years after the date of manifestation of 
     injury or 1 year after the claimant discovers, or through the 
     use of reasonable diligence should have discovered, the 
     injury, whichever occurs first.
       (b) General Exception.--The time for the commencement of a 
     health care lawsuit shall not exceed 3 years after the date 
     of manifestation of injury unless the tolling of time was 
     delayed as a result of--
       (1) fraud;
       (2) intentional concealment; or
       (3) the presence of a foreign body, which has no 
     therapeutic or diagnostic purpose or effect, in the person of 
     the injured person.
       (c) Minors.--An action by a minor shall be commenced within 
     3 years from the date of the alleged manifestation of injury 
     except that if such minor is under the full age of 6 years, 
     such action shall be commenced within 3 years of the 
     manifestation of injury, or prior to the eighth birthday of 
     the minor, whichever provides a longer period. Such time 
     limitation shall be tolled for minors for any period during 
     which a parent or guardian and a health care provider or 
     health care institution have committed fraud or collusion in 
     the failure to bring an action on behalf of the injured 
     minor.
       (d) Rule 11 Sanctions.--Whenever a Federal or State court 
     determines (whether by motion of the parties or whether on 
     the motion of the court) that there has been a violation of 
     Rule 11 of the Federal Rules of Civil Procedure (or a similar 
     violation of applicable State court rules) in a health care 
     liability action to which this title applies, the court shall 
     impose upon the attorneys, law firms, or pro se litigants 
     that have violated Rule 11 or are responsible for the 
     violation, an appropriate sanction, which shall include an 
     order to pay the other party or parties for the reasonable 
     expenses incurred as a direct result of the filing of the 
     pleading, motion, or other paper that is the subject of the 
     violation, including a reasonable attorneys' fee. Such 
     sanction shall be sufficient to deter repetition of such 
     conduct or comparable conduct by others similarly situated, 
     and to compensate the party or parties injured by such 
     conduct.

     SEC. _05. COMPENSATING PATIENT INJURY.

       (a) Unlimited Amount of Damages for Actual Economic Losses 
     in Health Care Lawsuits.--In any health care lawsuit, nothing

[[Page S13630]]

     in this title shall limit the recovery by a claimant of the 
     full amount of the available economic damages, 
     notwithstanding the limitation contained in subsection (b).
       (b) Additional Noneconomic Damages.--
       (1) Health care providers.--In any health care lawsuit 
     where final judgment is rendered against a health care 
     provider, the amount of noneconomic damages recovered from 
     the provider, if otherwise available under applicable Federal 
     or State law, may be as much as $250,000, regardless of the 
     number of parties other than a health care institution 
     against whom the action is brought or the number of separate 
     claims or actions brought with respect to the same 
     occurrence.
       (2) Health care institutions.--
       (A) Single institution.--In any health care lawsuit where 
     final judgment is rendered against a single health care 
     institution, the amount of noneconomic damages recovered from 
     the institution, if otherwise available under applicable 
     Federal or State law, may be as much as $250,000, regardless 
     of the number of parties against whom the action is brought 
     or the number of separate claims or actions brought with 
     respect to the same occurrence.
       (B) Multiple institutions.--In any health care lawsuit 
     where final judgment is rendered against more than one health 
     care institution, the amount of noneconomic damages recovered 
     from each institution, if otherwise available under 
     applicable Federal or State law, may be as much as $250,000, 
     regardless of the number of parties against whom the action 
     is brought or the number of separate claims or actions 
     brought with respect to the same occurrence, except that the 
     total amount recovered from all such institutions in such 
     lawsuit shall not exceed $500,000.
       (c) No Discount of Award for Noneconomic Damages.--In any 
     health care lawsuit--
       (1) an award for future noneconomic damages shall not be 
     discounted to present value;
       (2) the jury shall not be informed about the maximum award 
     for noneconomic damages under subsection (b);
       (3) an award for noneconomic damages in excess of the 
     limitations provided for in subsection (b) shall be reduced 
     either before the entry of judgment, or by amendment of the 
     judgment after entry of judgment, and such reduction shall be 
     made before accounting for any other reduction in damages 
     required by law; and
       (4) if separate awards are rendered for past and future 
     noneconomic damages and the combined awards exceed the 
     limitations provided for in subsection (b), the future 
     noneconomic damages shall be reduced first.
       (d) Fair Share Rule.--In any health care lawsuit, each 
     party shall be liable for that party's several share of any 
     damages only and not for the share of any other person. Each 
     party shall be liable only for the amount of damages 
     allocated to such party in direct proportion to such party's 
     percentage of responsibility. A separate judgment shall be 
     rendered against each such party for the amount allocated to 
     such party. For purposes of this section, the trier of fact 
     shall determine the proportion of responsibility of each 
     party for the claimant's harm.

     SEC. _06. MAXIMIZING PATIENT RECOVERY.

       (a) Court Supervision of Share of Damages Actually Paid to 
     Claimants.--
       (1) In general.--In any health care lawsuit, the court 
     shall supervise the arrangements for payment of damages to 
     protect against conflicts of interest that may have the 
     effect of reducing the amount of damages awarded that are 
     actually paid to claimants.
       (2) Contingency fees.--
       (A) In general.--In any health care lawsuit in which the 
     attorney for a party claims a financial stake in the outcome 
     by virtue of a contingent fee, the court shall have the power 
     to restrict the payment of a claimant's damage recovery to 
     such attorney, and to redirect such damages to the claimant 
     based upon the interests of justice and principles of equity.
       (B) Limitation.--The total of all contingent fees for 
     representing all claimants in a health care lawsuit shall not 
     exceed the following limits:
       (i) 40 percent of the first $50,000 recovered by the 
     claimant(s).
       (ii) 33\1/3\ percent of the next $50,000 recovered by the 
     claimant(s).
       (iii) 25 percent of the next $500,000 recovered by the 
     claimant(s).
       (iv) 15 percent of any amount by which the recovery by the 
     claimant(s) is in excess of $600,000.
       (b) Applicability.--
       (1) In general.--The limitations in subsection (a) shall 
     apply whether the recovery is by judgment, settlement, 
     mediation, arbitration, or any other form of alternative 
     dispute resolution.
       (2) Minors.--In a health care lawsuit involving a minor or 
     incompetent person, a court retains the authority to 
     authorize or approve a fee that is less than the maximum 
     permitted under this section.
       (c) Expert Witnesses.--
       (1) Requirement.--No individual shall be qualified to 
     testify as an expert witness concerning issues of negligence 
     in any health care lawsuit against a defendant unless such 
     individual--
       (A) except as required under paragraph (2), is a health 
     care professional who--
       (i) is appropriately credentialed or licensed in 1 or more 
     States to deliver health care services; and
       (ii) typically treats the diagnosis or condition or 
     provides the type of treatment under review; and
       (B) can demonstrate by competent evidence that, as a result 
     of training, education, knowledge, and experience in the 
     evaluation, diagnosis, and treatment of the disease or injury 
     which is the subject matter of the lawsuit against the 
     defendant, the individual was substantially familiar with 
     applicable standards of care and practice as they relate to 
     the act or omission which is the subject of the lawsuit on 
     the date of the incident.
       (2) Physician review.--In a health care lawsuit, if the 
     claim of the plaintiff involved treatment that is recommended 
     or provided by a physician (allopathic or osteopathic), an 
     individual shall not be qualified to be an expert witness 
     under this subsection with respect to issues of negligence 
     concerning such treatment unless such individual is a 
     physician.
       (3) Specialties and subspecialties.--With respect to a 
     lawsuit described in paragraph (1), a court shall not permit 
     an expert in one medical specialty or subspecialty to testify 
     against a defendant in another medical specialty or 
     subspecialty unless, in addition to a showing of substantial 
     familiarity in accordance with paragraph (1)(B), there is a 
     showing that the standards of care and practice in the two 
     specialty or subspecialty fields are similar.
       (4) Limitation.--The limitations in this subsection shall 
     not apply to expert witnesses testifying as to the degree or 
     permanency of medical or physical impairment.

     SEC. _07. ADDITIONAL HEALTH BENEFITS.

       (a) In General.--The amount of any damages received by a 
     claimant in any health care lawsuit shall be reduced by the 
     court by the amount of any collateral source benefits to 
     which the claimant is entitled, less any insurance premiums 
     or other payments made by the claimant (or by the spouse, 
     parent, child, or legal guardian of the claimant) to obtain 
     or secure such benefits.
       (b) Preservation of Current Law.--Where a payor of 
     collateral source benefits has a right of recovery by 
     reimbursement or subrogation and such right is permitted 
     under Federal or State law, subsection (a) shall not apply.
       (c) Application of Provision.--This section shall apply to 
     any health care lawsuit that is settled or resolved by a fact 
     finder.

     SEC. _08. PUNITIVE DAMAGES.

       (a) Punitive Damages Permitted.--
       (1) In general.--Punitive damages may, if otherwise 
     available under applicable State or Federal law, be awarded 
     against any person in a health care lawsuit only if it is 
     proven by clear and convincing evidence that such person 
     acted with malicious intent to injure the claimant, or that 
     such person deliberately failed to avoid unnecessary injury 
     that such person knew the claimant was substantially certain 
     to suffer.
       (2) Filing of lawsuit.--No demand for punitive damages 
     shall be included in a health care lawsuit as initially 
     filed. A court may allow a claimant to file an amended 
     pleading for punitive damages only upon a motion by the 
     claimant and after a finding by the court, upon review of 
     supporting and opposing affidavits or after a hearing, after 
     weighing the evidence, that the claimant has established by a 
     substantial probability that the claimant will prevail on the 
     claim for punitive damages.
       (3) Separate proceeding.--At the request of any party in a 
     health care lawsuit, the trier of fact shall consider in a 
     separate proceeding--
       (A) whether punitive damages are to be awarded and the 
     amount of such award; and
       (B) the amount of punitive damages following a 
     determination of punitive liability.
     If a separate proceeding is requested, evidence relevant only 
     to the claim for punitive damages, as determined by 
     applicable State law, shall be inadmissible in any proceeding 
     to determine whether compensatory damages are to be awarded.
       (4) Limitation where no compensatory damages are awarded.--
     In any health care lawsuit where no judgment for compensatory 
     damages is rendered against a person, no punitive damages may 
     be awarded with respect to the claim in such lawsuit against 
     such person.
       (b) Determining Amount of Punitive Damages.--
       (1) Factors considered.--In determining the amount of 
     punitive damages under this section, the trier of fact shall 
     consider only the following:
       (A) the severity of the harm caused by the conduct of such 
     party;
       (B) the duration of the conduct or any concealment of it by 
     such party;
       (C) the profitability of the conduct to such party;
       (D) the number of products sold or medical procedures 
     rendered for compensation, as the case may be, by such party, 
     of the kind causing the harm complained of by the claimant;
       (E) any criminal penalties imposed on such party, as a 
     result of the conduct complained of by the claimant; and
       (F) the amount of any civil fines assessed against such 
     party as a result of the conduct complained of by the 
     claimant.
       (2) Maximum award.--The amount of punitive damages awarded 
     in a health care lawsuit may not exceed an amount equal to 
     two times the amount of economic damages awarded in the 
     lawsuit or $250,000, whichever is greater. The jury shall not 
     be informed of the limitation under the preceding sentence.

[[Page S13631]]

       (c) Liability of Health Care Providers.--
       (1) In general.--A health care provider who prescribes, or 
     who dispenses pursuant to a prescription, a drug, biological 
     product, or medical device approved by the Food and Drug 
     Administration, for an approved indication of the drug, 
     biological product, or medical device, shall not be named as 
     a party to a product liability lawsuit invoking such drug, 
     biological product, or medical device and shall not be liable 
     to a claimant in a class action lawsuit against the 
     manufacturer, distributor, or product seller of such drug, 
     biological product, or medical device.
       (2) Medical product.--The term ``medical product'' means a 
     drug or device intended for humans. The terms ``drug'' and 
     ``device'' have the meanings given such terms in sections 
     201(g)(1) and 201(h) of the Federal Food, Drug and Cosmetic 
     Act (21 U.S.C. 321), respectively, including any component or 
     raw material used therein, but excluding health care 
     services.

     SEC. _09. AUTHORIZATION OF PAYMENT OF FUTURE DAMAGES TO 
                   CLAIMANTS IN HEALTH CARE LAWSUITS.

       (a) In General.--In any health care lawsuit, if an award of 
     future damages, without reduction to present value, equaling 
     or exceeding $50,000 is made against a party with sufficient 
     insurance or other assets to fund a periodic payment of such 
     a judgment, the court shall, at the request of any party, 
     enter a judgment ordering that the future damages be paid by 
     periodic payments. In any health care lawsuit, the court may 
     be guided by the Uniform Periodic Payment of Judgments Act 
     promulgated by the National Conference of Commissioners on 
     Uniform State Laws.
       (b) Applicability.--This section applies to all actions 
     which have not been first set for trial or retrial before the 
     effective date of this title.

     SEC. _10. EFFECT ON OTHER LAWS.

       (a) General Vaccine Injury.--
       (1) In general.--To the extent that title XXI of the Public 
     Health Service Act establishes a Federal rule of law 
     applicable to a civil action brought for a vaccine-related 
     injury or death--
       (A) this title shall not affect the application of the rule 
     of law to such an action; and
       (B) any rule of law prescribed by this title in conflict 
     with a rule of law of such title XXI shall not apply to such 
     action.
       (2) Exception.--If there is an aspect of a civil action 
     brought for a vaccine-related injury or death to which a 
     Federal rule of law under title XXI of the Public Health 
     Service Act does not apply, then this title or otherwise 
     applicable law (as determined under this title) will apply to 
     such aspect of such action.
       (b) Smallpox Vaccine Injury.--
       (1) In general.--To the extent that part C of title II of 
     the Public Health Service Act establishes a Federal rule of 
     law applicable to a civil action brought for a smallpox 
     vaccine-related injury or death--
       (A) this title shall not affect the application of the rule 
     of law to such an action; and
       (B) any rule of law prescribed by this title in conflict 
     with a rule of law of such part C shall not apply to such 
     action.
       (2) Exception.--If there is an aspect of a civil action 
     brought for a smallpox vaccine-related injury or death to 
     which a Federal rule of law under part C of title II of the 
     Public Health Service Act does not apply, then this title or 
     otherwise applicable law (as determined under this title) 
     will apply to such aspect of such action.
       (c) Other Federal Law.--Except as provided in this section, 
     nothing in this title shall be deemed to affect any defense 
     available, or any limitation on liability that applies to, a 
     defendant in a health care lawsuit or action under any other 
     provision of Federal law.

     SEC. _11. STATE FLEXIBILITY AND PROTECTION OF STATES' RIGHTS.

       (a) Health Care Lawsuits.--The provisions governing health 
     care lawsuits set forth in this title shall preempt, subject 
     to subsections (b) and (c), State law to the extent that 
     State law prevents the application of any provisions of law 
     established by or under this title. The provisions governing 
     health care lawsuits set forth in this title supersede 
     chapter 171 of title 28, United States Code, to the extent 
     that such chapter--
       (1) provides for a greater amount of damages or contingent 
     fees, a longer period in which a health care lawsuit may be 
     commenced, or a reduced applicability or scope of periodic 
     payment of future damages, than provided in this title; or
       (2) prohibits the introduction of evidence regarding 
     collateral source benefits.
       (b) Preemption of Certain State Laws.--No provision of this 
     title shall be construed to preempt any State law (whether 
     effective before, on, or after the date of the enactment of 
     this Act) that specifies a particular monetary amount of 
     compensatory or punitive damages (or the total amount of 
     damages) that may be awarded in a health care lawsuit, 
     regardless of whether such monetary amount is greater or 
     lesser than is provided for under this title, notwithstanding 
     section _05(a).
       (c) Protection of State's Rights and Other Laws.--
       (1) In general.--Any issue that is not governed by a 
     provision of law established by or under this title 
     (including the State standards of negligence) shall be 
     governed by otherwise applicable Federal or State law.
       (2) Rule of construction.--Nothing in this title shall be 
     construed to--
       (A) preempt or supersede any Federal or State law that 
     imposes greater procedural or substantive protections for a 
     health care provider or health care institution from 
     liability, loss, or damages than those provided by this 
     title;
       (B) preempt or supercede any State law that permits and 
     provides for the enforcement of any arbitration agreement 
     related to a health care liability claim whether enacted 
     prior to or after the date of enactment of this Act;
       (C) create a cause of action that is not otherwise 
     available under Federal or State law; or
       (D) affect the scope of preemption of any other Federal 
     law.

     SEC. _12. APPLICABILITY; EFFECTIVE DATE.

       This title shall apply to any health care lawsuit brought 
     in a Federal or State court, or subject to an alternative 
     dispute resolution system, that is initiated on or after the 
     date of the enactment of this Act, except that any health 
     care lawsuit arising from an injury occurring prior to the 
     date of enactment of this Act shall be governed by the 
     applicable statute of limitations provisions in effect at the 
     time the injury occurred.
                                 ______
                                 
  SA 3285. Mr. GREGG submitted an amendment intended to be proposed to 
amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       On page 80, line 22, strike ``and''.
       On page 80, after line 25, add the following:
       ``(i) adherence to or participation in reasonably designed 
     programs of health promotion and disease prevention, if such 
     programs exist; and''.
       On page 81, line 4, insert before the period the following: 
     ``, except that group health plans and health insurance 
     issuers offering group or individual health insurance 
     coverage may establish premium discounts or rebates for 
     modifying otherwise applicable copayments or deductibles in 
     return for adherence to or participation in reasonably 
     designed programs of health promotion or disease 
     prevention''.
       Beginning on page 84, strike line 15 and all that follows 
     through line 3 on page 94, and insert the following:
       ``(j) Programs of Health Promotion or Disease Prevention.--
       ``(1) General provisions.--
       ``(A) General rule.--For purposes of subsection (b)(2)(B), 
     a program of health promotion or disease prevention (referred 
     to in this subsection as a `wellness program') shall be a 
     program that is designed to promote health or prevent disease 
     that meets the applicable requirements of this subsection.
       ``(B) No conditions based on health status factor.--If none 
     of the conditions for obtaining a premium discount or rebate 
     or other reward for participation in a wellness program is 
     based on an individual satisfying a standard that is related 
     to a health status factor, such wellness program shall not 
     violate this section if participation in the program is made 
     available to all similarly situated individuals and the 
     requirements of paragraph (2) are complied with.
       ``(C) Conditions based on health status factor.--If any of 
     the conditions for obtaining a premium discount or rebate or 
     other reward for participation in a wellness program is based 
     on an individual satisfying a standard that is related to a 
     health status factor, such wellness program shall not violate 
     this section if the requirements of paragraph (3) are 
     complied with.
       ``(2) Wellness programs not subject to requirements.--If 
     none of the conditions for obtaining a premium discount or 
     rebate or other reward under a wellness program as described 
     in paragraph (1)(B) are based on an individual satisfying a 
     standard that is related to a health status factor (or if 
     such a wellness program does not provide such a reward), the 
     wellness program shall not violate this section if 
     participation in the program is made available to all 
     similarly situated individuals. The following programs shall 
     not have to comply with the requirements of paragraph (3) if 
     participation in the program is made available to all 
     similarly situated individuals:
       ``(A) A program that reimburses all or part of the cost for 
     memberships in a fitness center.
       ``(B) A diagnostic testing program that provides a reward 
     for participation and does not base any part of the reward on 
     outcomes.
       ``(C) A program that encourages preventive care related to 
     a health condition through the waiver of the copayment or 
     deductible requirement under an individual or group health 
     plan for the costs of certain items or services related to a 
     health condition (such as prenatal care or well-baby visits).
       ``(D) A program that reimburses individuals for the costs 
     of smoking cessation programs without regard to whether the 
     individual quits smoking.
       ``(E) A program that provides a reward to individuals for 
     attending a periodic health education seminar.
       ``(3) Wellness programs subject to requirements.--If any of 
     the conditions for obtaining a premium discount, rebate, or 
     reward under a wellness program as described

[[Page S13632]]

     in paragraph (1)(C) is based on an individual satisfying a 
     standard that is related to a health status factor, the 
     wellness program shall not violate this section if the 
     following requirements are complied with:
       ``(A) The reward for the wellness program, together with 
     the reward for other wellness programs with respect to the 
     plan that requires satisfaction of a standard related to a 
     health status factor, shall not exceed 30 percent of the cost 
     of employee-only coverage under the plan. If, in addition to 
     employees or individuals, any class of dependents (such as 
     spouses or spouses and dependent children) may participate 
     fully in the wellness program, such reward shall not exceed 
     30 percent of the cost of the coverage in which an employee 
     or individual and any dependents are enrolled. For purposes 
     of this paragraph, the cost of coverage shall be determined 
     based on the total amount of employer and employee 
     contributions for the benefit package under which the 
     employee is (or the employee and any dependents are) 
     receiving coverage. A reward may be in the form of a discount 
     or rebate of a premium or contribution, a waiver of all or 
     part of a cost-sharing mechanism (such as deductibles, 
     copayments, or coinsurance), the absence of a surcharge, or 
     the value of a benefit that would otherwise not be provided 
     under the plan. The Secretaries of Labor, Health and Human 
     Services, and the Treasury may increase the reward available 
     under this subparagraph to up to 50 percent of the cost of 
     coverage if the Secretaries determine that such an increase 
     is appropriate.
       ``(B) The wellness program shall be reasonably designed to 
     promote health or prevent disease. A program complies with 
     the preceding sentence if the program has a reasonable chance 
     of improving the health of, or preventing disease in, 
     participating individuals and it is not overly burdensome, is 
     not a subterfuge for discriminating based on a health status 
     factor, and is not highly suspect in the method chosen to 
     promote health or prevent disease. The plan or issuer shall 
     evaluate the program's reasonableness at least once per year.
       ``(C) The plan shall give individuals eligible for the 
     program the opportunity to qualify for the reward under the 
     program at least once each year.
       ``(D) The full reward under the wellness program shall be 
     made available to all similarly situated individuals. For 
     such purpose, among other things:
       ``(i) The reward is not available to all similarly situated 
     individuals for a period unless the wellness program allows--

       ``(I) for a reasonable alternative standard (or waiver of 
     the otherwise applicable standard) for obtaining the reward 
     for any individual for whom, for that period, it is 
     unreasonably difficult due to a medical condition to satisfy 
     the otherwise applicable standard; and
       ``(II) for a reasonable alternative standard (or waiver of 
     the otherwise applicable standard) for obtaining the reward 
     for any individual for whom, for that period, it is medically 
     inadvisable to attempt to satisfy the otherwise applicable 
     standard.

       ``(ii) If reasonable under the circumstances, the plan or 
     issuer may seek verification, such as a statement from an 
     individual's physician, that a health status factor makes it 
     unreasonably difficult or medically inadvisable for the 
     individual to satisfy or attempt to satisfy the otherwise 
     applicable standard.
       ``(E) The plan or issuer involved shall disclose in all 
     plan materials describing the terms of the wellness program 
     the availability of a reasonable alternative standard (or the 
     possibility of waiver of the otherwise applicable standard) 
     required under subparagraph (D). If plan materials disclose 
     that such a program is available, without describing its 
     terms, the disclosure under this subparagraph shall not be 
     required.
       ``(k) Existing Programs.--Nothing in this section shall 
     prohibit a program of health promotion or disease prevention 
     that was established prior to the date of enactment of this 
     section and applied with all applicable regulations, and that 
     is operating on such date, from continuing to be carried out 
     for as long as such regulations remain in effect.
       ``(l) Regulations.--Nothing in this section shall be 
     construed as prohibiting the Secretaries of Labor, Health and 
     Human Services, or the Treasury from promulgating regulations 
     in connection with this section.''.
                                 ______
                                 
  SA 3286. Mr. GREGG submitted an amendment intended to be proposed to 
amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       On page 114, beginning with line 17, strike all through 
     page 116, line 6, and insert the following:
       (e) Catastrophic Plan.--A health plan not providing a 
     bronze, silver, gold, or platinum level of coverage shall be 
     treated as meeting the requirements of subsection (d) with 
     respect to any plan year if the plan provides--
       (1) except as provided in paragraph (1), the essential 
     health benefits determined under subsection (b), except that 
     the plan provides no benefits for any plan year until the 
     individual has incurred cost-sharing expenses in an amount 
     equal to the annual limitation in effect under subsection 
     (c)(1) for the plan year (except as provided for in section 
     2713); and
       (2) coverage for at least three primary care visits.
       On page 155, beginning with line 22, strike all through 
     page 156, line 3, and insert the following:
       (A) Individuals allowed to enroll in any plan.--A qualified 
     individual may enroll in any qualified health plan.
       On page 250, lines 7 through 10, strike ``, except that 
     such term shall not include a qualified health plan which is 
     a catastrophic health plan described in section 1302(e) of 
     such Act''.
                                 ______
                                 
  SA 3287. Mr. GREGG submitted an amendment intended to be proposed to 
amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       At the appropriate place, insert the following:

     SEC. __. PREVENTING THE GAMING OF THE 10 YEAR BUDGET WINDOW.

       Section 402 of the Congressional Budget Act of 1974 5 (2 
     U.S. C. 653) is amended--
       (1) in paragraph (2), by striking ``and'' after the 
     semicolon;
       (2) in paragraph (3), by striking the period and insert ``; 
     and''; and
       (3) by inserting at the end the following:
       ``(4) for any provisions with delayed effective dates or 
     phase-in periods, an estimate of the costs for the year that 
     the provision first becomes fully effective and for each of 
     the following 9 fiscal years.''.
                                 ______
                                 
  SA 3288. Mr. REID submitted an amendment intended to be proposed to 
amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       At the end of the amendment, insert the following: The 
     provisions of this section shall be effective upon enactment.
                                 ______
                                 
  SA 3289. Mr. REID submitted an amendment intended to be proposed to 
amendment SA 3289 submitted by Mr. Reid and intended to be proposed to 
the amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, 
Mr. Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       In the amendment, strike ``upon enactment'' and insert ``5 
     days after enactment''.
                                 ______
                                 
  SA 3290. Mr. REID submitted an amendment intended to be proposed by 
him to the bill H.R. 3590, to amend the Internal Revenue Code of 1986 
to modify the first-time homebuyers credit in the case of members of 
the Armed Forces and certain other Federal employees, and for other 
purposes; which was ordered to lie on the table; as follows:

       At the end of the language proposed to be stricken, insert 
     the following:
       This section shall become effective 4 days after enactment.
                                 ______
                                 
  SA 3291. Mr. REID submitted an amendment intended to be proposed to 
amendment SA 3290 submitted by Mr. Reid and intended to be proposed to 
the bill H.R. 3590, to amend the Internal Revenue Code of 1986 to 
modify the first-time homebuyers credit in the case of members of the 
Armed Forces and certain other Federal employees, and for other 
purposes; which was orded to lie on the table; as follows:

       In the amendment, strike ``upon enactment'' and insert ``5 
     days after enactment''.
                                 ______
                                 
  SA 3292. Mr. REID submitted an amendment intended to be proposed by 
him to the bill H.R. 3590, to amend the Internal Revenue Code of 1986 
to modify the first-time homebuyers credit in the case of members of 
the Armed Forces and certain other Federal employees, and for other 
purposes; which was ordered to lie on the table; as follows:

       At the end of the amendment, insert the following:

[[Page S13633]]

       This section shall become effective 5 days after enactment.
                                 ______
                                 
  SA 3293. Mr. McCAIN submitted an amendment intended to be proposed to 
amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr. 
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal 
Revenue Code of 1986 to modify the first-time homebuyers credit in the 
case of members of the Armed Forces and certain other Federal 
employees, and for other purposes; which was ordered to lie on the 
table; as follows:

       Beginning on page 1859, strike line 6 and all that follows 
     through line 5 on page 1906, and insert the following:

      Subtitle A--Patient Access to Safe and Competitive Biologics

     SEC. 7001. SHORT TITLE.

       (a) In General.--This subtitle may be cited as the 
     ``Patient Access to Safe and Competitive Biologics Act''.
       (b) Sense of the Senate.--It is the sense of the Senate 
     that a biosimilars pathway balancing innovation and consumer 
     interests should be established.

     SEC. 7002. APPROVAL PATHWAY FOR BIOSIMILAR BIOLOGICAL 
                   PRODUCTS.

       (a) Licensure of Biological Products as Biosimilar or 
     Therapeutically Equivalent.--Section 351 of the Public Health 
     Service Act (42 U.S.C. 262) is amended--
       (1) in subsection (a)(1)(A), by inserting ``under this 
     subsection or subsection (k)'' after ``biologics license''; 
     and
       (2) by adding at the end the following:
       ``(k) Licensure of Biological Products as Biosimilar or 
     Therapeutically Equivalent.--
       ``(1) In general.--Any person may submit an application for 
     licensure of a biological product under this subsection.
       ``(2) Content.--
       ``(A) In general.--
       ``(i) Required information.--An application submitted under 
     this subsection shall include information demonstrating 
     that--

       ``(I) the biological product is biosimilar to a reference 
     product based upon data derived from--

       ``(aa) analytical studies that demonstrate that the 
     biological product is highly similar to the reference product 
     notwithstanding minor differences in clinically inactive 
     components;
       ``(bb) animal studies (including the assessment of 
     toxicity); and
       ``(cc) a clinical study or studies (including the 
     assessment of immunogenicity and pharmacokinetics or 
     pharmacodynamics) conducted by the applicant that are 
     sufficient to demonstrate safety, purity, and potency in 1 or 
     more appropriate conditions of use for which the reference 
     product is licensed and intended to be used and for which 
     licensure is sought for the biological product;

       ``(II) the biological product and reference product utilize 
     the same mechanism or mechanisms of action for the condition 
     or conditions of use prescribed, recommended, or suggested in 
     the proposed labeling, but only to the extent the mechanism 
     or mechanisms of action are known for the reference product;
       ``(III) the condition or conditions of use prescribed, 
     recommended, or suggested in the labeling proposed for the 
     biological product have been previously approved for the 
     reference product;
       ``(IV) the route of administration, the dosage form, and 
     the strength of the biological product are the same as those 
     of the reference product; and
       ``(V) the facility in which the biological product is 
     manufactured, processed, packed, or held meets standards 
     designed to assure that the biological product continues to 
     be safe, pure, and potent.

       ``(ii) Determination by secretary.--The Secretary may 
     determine, after public notice and comment, that an element 
     described in item (aa) or (bb) of clause (i)(I) is 
     unnecessary in an application submitted under this 
     subsection.
       ``(iii) Additional information.--An application submitted 
     under this subsection--

       ``(I) shall include publicly-available information 
     regarding the Secretary's previous determination that the 
     reference product is safe, pure, and potent; and
       ``(II) may include any additional information in support of 
     the application, including publicly-available information 
     with respect to the reference product or another biological 
     product.

       ``(B) Therapeutic equivalence.--If a sponsor submits an 
     application (or supplement to an application) under this 
     subsection claiming that the biologics product is 
     therapeutically equivalent to the reference product, such 
     application (or supplement) shall include information 
     demonstrating that the biological product meets the standards 
     described in paragraph (4)(A).
       ``(3) Evaluation by secretary.--Upon review of an 
     application (or a supplement to an application) submitted 
     under this subsection, the Secretary shall license the 
     biological product under this subsection if--
       ``(A) the Secretary determines that the information 
     submitted in the application (or the supplement) is 
     sufficient to show that the biological product--
       ``(i) is biosimilar to the reference product; or
       ``(ii) meets the standards described in paragraph (4)(A), 
     and therefore is therapeutically equivalent to the reference 
     product; and
       ``(B) the applicant (or other appropriate person) consents 
     to the inspection of the facility that is the subject of the 
     application, in accordance with subsection (c).
       ``(4) Safety standards for determining therapeutic 
     equivalence.--
       ``(A) Determination by the secretary.--Upon review of an 
     application submitted under this subsection or any supplement 
     to such application, the Secretary shall determine the 
     biological product to have demonstrated therapeutic 
     equivalence to the reference product if the Secretary 
     determines that the information submitted in the application 
     (or a supplement to such application) is sufficient to show 
     that--
       ``(i) the biological product--

       ``(I) is biosimilar to the reference product; and
       ``(II) can be expected to produce the same clinical result 
     as the reference product in any given patient; and

       ``(ii) for a biological product that is administered more 
     than once to an individual, the risk in terms of safety or 
     diminished efficacy of alternating or switching between use 
     of the biological product and the reference product is not 
     greater than the risk of using the reference product without 
     such alternation or switch.
       ``(B) Application of therapeutic equivalence only with 
     prescription.--Notwithstanding any other provision of law, no 
     biological product determined to be therapeutically 
     equivalent to a reference product under subparagraph (A) 
     shall be deemed to be therapeutically appropriate with 
     respect to an individual unless so determined by a health 
     care professional treating such individual.
       ``(5) General rules.--
       ``(A) One reference product per application.--A biological 
     product, in an application submitted under this subsection, 
     may not be evaluated against more than 1 reference product.
       ``(B) Review.--An application submitted under this 
     subsection shall be reviewed by the division within the Food 
     and Drug Administration that is responsible for the review 
     and approval of the application under which the reference 
     product is licensed.
       ``(C) Risk evaluation and mitigation strategies.--The 
     authority of the Secretary with respect to risk evaluation 
     and mitigation strategies under the Federal Food, Drug, and 
     Cosmetic Act shall apply to biological products licensed 
     under this subsection in the same manner as such authority 
     applies to biological products licensed under subsection (a).
       ``(6) Exclusivity for first therapeutically equivalent 
     biological product.--Upon review of an application submitted 
     under this subsection relying on the same reference product 
     for which a prior biological product has received a 
     determination of therapeutic equivalence for any condition of 
     use, the Secretary shall not make a determination under 
     paragraph (4)(A) that the second or subsequent biological 
     product is therapeutically equivalent for any condition of 
     use until the earlier of--
       ``(A) 1 year after the first commercial marketing of the 
     first biosimilar biological product to be approved as 
     therapeutically equivalent for that reference product;
       ``(B) 18 months after--
       ``(i) a final court decision on all patents in suit in an 
     action instituted under subsection (l)(6) against the 
     applicant that submitted the application for the first 
     approved therapeutically equivalent biosimilar biological 
     product; or
       ``(ii) the dismissal with or without prejudice of an action 
     instituted under subsection (l)(6) against the applicant that 
     submitted the application for the first approved 
     therapeutically equivalent biosimilar biological product; or
       ``(C)(i) 42 months after approval of the first 
     therapeutically equivalent biosimilar biological product if 
     the applicant that submitted such application has been sued 
     under subsection (l)(6) and such litigation is still ongoing 
     within such 42-month period; or
       ``(ii) 18 months after approval of the first 
     therapeutically equivalent biosimilar biological product if 
     the applicant that submitted such application has not been 
     sued under subsection (l)(6).

     For purposes of this paragraph, the term `final court 
     decision' means a final decision of a court from which no 
     appeal (other than a petition to the United States Supreme 
     Court for a writ of certiorari) has been or can be taken.
       ``(7) Exclusivity for reference product.--
       ``(A) Effective date of biosimilar application approval.--
       ``(i) In general.--Except as provided in clause (ii) and 
     (iii), approval of an application under this subsection may 
     not be made effective by the Secretary until the date that is 
     10 years after the date on which the reference product was 
     first licensed under subsection (a).
       ``(ii) Extension of exclusivity.--The period of exclusivity 
     described in clause (i) for a reference product shall be 
     extended for an additional 2 years beyond the 10 years 
     provided in such clause if the sponsor or manufacturer of the 
     reference product submits a subsequent application for a 
     change (not including a modification to the structure of the 
     reference product) that results in a new indication for the 
     reference product.
       ``(iii) Significant therapeutic advancement.--If a 
     reference product represents a

[[Page S13634]]

     significant therapeutic advancement (including a modification 
     that results in a new dosage form, new dosing regimen, or new 
     route of administration of such biological product) of a 
     biological product that was previously licensed under 
     subsection (a) and that has the same sponsor or manufacturer 
     as such reference product, then the period of exclusivity for 
     such reference product shall be the number of years equal to 
     the sum of--

       ``(I) the remaining period of exclusivity under clause (i) 
     for biological product on which the reference product 
     representing the significant therapeutic advancement was 
     based, plus
       ``(II) 2 years.

       ``(iv) No extension for significant therapeutic 
     advancement.--In no case may the period of exclusivity under 
     clause (iii) be extended.
       ``(B) Filing period.--An application under this subsection 
     may not be submitted to the Secretary until the date that is 
     4 years after the date on which the reference product was 
     first licensed under subsection (a).
       ``(C) First licensure.--The date on which the reference 
     product was first licensed under subsection (a) does not 
     include the date of approval of a supplement or of a 
     subsequent application for a new indication, route of 
     administration, dosage form, or strength for the previously 
     licensed reference product.
       ``(8) Guidance documents.--
       ``(A) In general.--The Secretary may, after opportunity for 
     public comment, issue guidance in accordance, except as 
     provided in subparagraph (B)(i), with section 701(h) of the 
     Federal Food, Drug, and Cosmetic Act with respect to the 
     licensure of a biological product under this subsection. Any 
     such guidance may be general or specific.
       ``(B) Public comment.--
       ``(i) In general.--The Secretary shall provide the public 
     an opportunity to comment on any proposed guidance issued 
     under subparagraph (A) before issuing final guidance.
       ``(ii) Input regarding most valuable guidance.--The 
     Secretary shall establish a process through which the public 
     may provide the Secretary with input regarding priorities for 
     issuing guidance.
       ``(C) No requirement for application consideration.--The 
     issuance (or non-issuance) of guidance under subparagraph (A) 
     shall not preclude the review of, or action on, an 
     application submitted under this subsection.
       ``(D) Requirement for product class-specific guidance.--If 
     the Secretary issues product class-specific guidance under 
     subparagraph (A), such guidance shall include a description 
     of--
       ``(i) the criteria that the Secretary will use to determine 
     whether a biological product is highly similar to a reference 
     product in such product class; and
       ``(ii) the criteria, if available, that the Secretary will 
     use to determine whether a biological product meets the 
     standards described in paragraph (4)(A).
       ``(E) Certain product classes.--
       ``(i) Guidance.--The Secretary may indicate in a guidance 
     document that the science and experience, as of the date of 
     such guidance, with respect to a product or product class 
     (not including any recombinant protein) does not allow 
     approval of an application for a license as provided under 
     this subsection for such product or product class.
       ``(ii) Modification or reversal.--The Secretary may issue a 
     subsequent guidance document under subparagraph (A) to modify 
     or reverse a guidance document under clause (i).
       ``(iii) No effect on ability to deny license.--Clause (i) 
     shall not be construed to require the Secretary to approve a 
     product with respect to which the Secretary has not indicated 
     in a guidance document that the science and experience, as 
     described in clause (i), does not allow approval of such an 
     application.
       ``(l) Patents.--
       ``(1) Confidential access to subsection (k) application.--
       ``(A) Application of paragraph.--Unless otherwise agreed to 
     by a person that submits an application under subsection (k) 
     (referred to in this subsection as the `subsection (k) 
     applicant') and the sponsor of the application for the 
     reference product (referred to in this subsection as the 
     `reference product sponsor'), the provisions of this 
     paragraph shall apply to the exchange of information 
     described in this subsection.
       ``(B) In general.--
       ``(i) Provision of confidential information.--When a 
     subsection (k) applicant submits an application under 
     subsection (k), such applicant shall provide to the persons 
     described in clause (ii), subject to the terms of this 
     paragraph, confidential access to the information required to 
     be produced pursuant to paragraph (2) and any other 
     information that the subsection (k) applicant determines, in 
     its sole discretion, to be appropriate (referred to in this 
     subsection as the `confidential information').
       ``(ii) Recipients of information.--The persons described in 
     this clause are the following:

       ``(I) Outside counsel.--One or more attorneys designated by 
     the reference product sponsor who are employees of an entity 
     other than the reference product sponsor (referred to in this 
     paragraph as the `outside counsel'), provided that such 
     attorneys do not engage, formally or informally, in patent 
     prosecution relevant or related to the reference product.
       ``(II) In-house counsel.--One attorney that represents the 
     reference product sponsor who is an employee of the reference 
     product sponsor, provided that such attorney does not engage, 
     formally or informally, in patent prosecution relevant or 
     related to the reference product.

       ``(iii) Patent owner access.--A representative of the owner 
     of a patent exclusively licensed to a reference product 
     sponsor with respect to the reference product and who has 
     retained a right to assert the patent or participate in 
     litigation concerning the patent may be provided the 
     confidential information, provided that the representative 
     informs the reference product sponsor and the subsection (k) 
     applicant of his or her agreement to be subject to the 
     confidentiality provisions set forth in this paragraph, 
     including those under clause (ii).
       ``(C) Limitation on disclosure.--No person that receives 
     confidential information pursuant to subparagraph (B) shall 
     disclose any confidential information to any other person or 
     entity, including the reference product sponsor employees, 
     outside scientific consultants, or other outside counsel 
     retained by the reference product sponsor, without the prior 
     written consent of the subsection (k) applicant, which shall 
     not be unreasonably withheld.
       ``(D) Use of confidential information.--Confidential 
     information shall be used for the sole and exclusive purpose 
     of determining, with respect to each patent assigned to or 
     exclusively licensed by the reference product sponsor, 
     whether a claim of patent infringement could reasonably be 
     asserted if the subsection (k) applicant engaged in the 
     manufacture, use, offering for sale, sale, or importation 
     into the United States of the biological product that is the 
     subject of the application under subsection (k).
       ``(E) Ownership of confidential information.--The 
     confidential information disclosed under this paragraph is, 
     and shall remain, the property of the subsection (k) 
     applicant. By providing the confidential information pursuant 
     to this paragraph, the subsection (k) applicant does not 
     provide the reference product sponsor or the outside counsel 
     any interest in or license to use the confidential 
     information, for purposes other than those specified in 
     subparagraph (D).
       ``(F) Effect of infringement action.--In the event that the 
     reference product sponsor files a patent infringement suit, 
     the use of confidential information shall continue to be 
     governed by the terms of this paragraph until such time as a 
     court enters a protective order regarding the information. 
     Upon entry of such order, the subsection (k) applicant may 
     redesignate confidential information in accordance with the 
     terms of that order. No confidential information shall be 
     included in any publicly-available complaint or other 
     pleading. In the event that the reference product sponsor 
     does not file an infringement action by the date specified in 
     paragraph (6), the reference product sponsor shall return or 
     destroy all confidential information received under this 
     paragraph, provided that if the reference product sponsor 
     opts to destroy such information, it will confirm destruction 
     in writing to the subsection (k) applicant.
       ``(G) Rule of construction.--Nothing in this paragraph 
     shall be construed--
       ``(i) as an admission by the subsection (k) applicant 
     regarding the validity, enforceability, or infringement of 
     any patent; or
       ``(ii) as an agreement or admission by the subsection (k) 
     applicant with respect to the competency, relevance, or 
     materiality of any confidential information.
       ``(H) Effect of violation.--The disclosure of any 
     confidential information in violation of this paragraph shall 
     be deemed to cause the subsection (k) applicant to suffer 
     irreparable harm for which there is no adequate legal remedy 
     and the court shall consider immediate injunctive relief to 
     be an appropriate and necessary remedy for any violation or 
     threatened violation of this paragraph.
       ``(2) Subsection (k) application information.--Not later 
     than 20 days after the Secretary notifies the subsection (k) 
     applicant that the application has been accepted for review, 
     the subsection (k) applicant--
       ``(A) shall provide to the reference product sponsor a copy 
     of the application submitted to the Secretary under 
     subsection (k), and such other information that describes the 
     process or processes used to manufacture the biological 
     product that is the subject of such application; and
       ``(B) may provide to the reference product sponsor 
     additional information requested by or on behalf of the 
     reference product sponsor.
       ``(3) List and description of patents.--
       ``(A) List by reference product sponsor.--Not later than 60 
     days after the receipt of the application and information 
     under paragraph (2), the reference product sponsor shall 
     provide to the subsection (k) applicant--
       ``(i) a list of patents for which the reference product 
     sponsor believes a claim of patent infringement could 
     reasonably be asserted by the reference product sponsor, or 
     by a patent owner that has granted an exclusive license to 
     the reference product sponsor with respect to the reference 
     product, if a person not licensed by the reference product 
     sponsor engaged in the making, using, offering to sell, 
     selling, or importing into the United States of the 
     biological product that is the subject of the subsection (k) 
     application; and
       ``(ii) an identification of the patents on such list that 
     the reference product sponsor would be prepared to license to 
     the subsection (k) applicant.

[[Page S13635]]

       ``(B) List and description by subsection (k) applicant.--
     Not later than 60 days after receipt of the list under 
     subparagraph (A), the subsection (k) applicant--
       ``(i) may provide to the reference product sponsor a list 
     of patents to which the subsection (k) applicant believes a 
     claim of patent infringement could reasonably be asserted by 
     the reference product sponsor if a person not licensed by the 
     reference product sponsor engaged in the making, using, 
     offering to sell, selling, or importing into the United 
     States of the biological product that is the subject of the 
     subsection (k) application;
       ``(ii) shall provide to the reference product sponsor, with 
     respect to each patent listed by the reference product 
     sponsor under subparagraph (A) or listed by the subsection 
     (k) applicant under clause (i)--

       ``(I) a detailed statement that describes, on a claim by 
     claim basis, the factual and legal basis of the opinion of 
     the subsection (k) applicant that such patent is invalid, 
     unenforceable, or will not be infringed by the commercial 
     marketing of the biological product that is the subject of 
     the subsection (k) application; or
       ``(II) a statement that the subsection (k) applicant does 
     not intend to begin commercial marketing of the biological 
     product before the date that such patent expires; and

       ``(iii) shall provide to the reference product sponsor a 
     response regarding each patent identified by the reference 
     product sponsor under subparagraph (A)(ii).
       ``(C) Description by reference product sponsor.--Not later 
     than 60 days after receipt of the list and statement under 
     subparagraph (B), the reference product sponsor shall provide 
     to the subsection (k) applicant a detailed statement that 
     describes, with respect to each patent described in 
     subparagraph (B)(ii)(I), on a claim by claim basis, the 
     factual and legal basis of the opinion of the reference 
     product sponsor that such patent will be infringed by the 
     commercial marketing of the biological product that is the 
     subject of the subsection (k) application and a response to 
     the statement concerning validity and enforceability provided 
     under subparagraph (B)(ii)(I).
       ``(4) Patent resolution negotiations.--
       ``(A) In general.--After receipt by the subsection (k) 
     applicant of the statement under paragraph (3)(C), the 
     reference product sponsor and the subsection (k) applicant 
     shall engage in good faith negotiations to agree on which, if 
     any, patents listed under paragraph (3) by the subsection (k) 
     applicant or the reference product sponsor shall be the 
     subject of an action for patent infringement under paragraph 
     (6).
       ``(B) Failure to reach agreement.--If, within 15 days of 
     beginning negotiations under subparagraph (A), the subsection 
     (k) applicant and the reference product sponsor fail to agree 
     on a final and complete list of which, if any, patents listed 
     under paragraph (3) by the subsection (k) applicant or the 
     reference product sponsor shall be the subject of an action 
     for patent infringement under paragraph (6), the provisions 
     of paragraph (5) shall apply to the parties.
       ``(5) Patent resolution if no agreement.--
       ``(A) Number of patents.--The subsection (k) applicant 
     shall notify the reference product sponsor of the number of 
     patents that such applicant will provide to the reference 
     product sponsor under subparagraph (B)(i)(I).
       ``(B) Exchange of patent lists.--
       ``(i) In general.--On a date agreed to by the subsection 
     (k) applicant and the reference product sponsor, but in no 
     case later than 5 days after the subsection (k) applicant 
     notifies the reference product sponsor under subparagraph 
     (A), the subsection (k) applicant and the reference product 
     sponsor shall simultaneously exchange--

       ``(I) the list of patents that the subsection (k) applicant 
     believes should be the subject of an action for patent 
     infringement under paragraph (6); and
       ``(II) the list of patents, in accordance with clause (ii), 
     that the reference product sponsor believes should be the 
     subject of an action for patent infringement under paragraph 
     (6).

       ``(ii) Number of patents listed by reference product 
     sponsor.--

       ``(I) In general.--Subject to subclause (II), the number of 
     patents listed by the reference product sponsor under clause 
     (i)(II) may not exceed the number of patents listed by the 
     subsection (k) applicant under clause (i)(I).
       ``(II) Exception.--If a subsection (k) applicant does not 
     list any patent under clause (i)(I), the reference product 
     sponsor may list 1 patent under clause (i)(II).

       ``(6) Immediate patent infringement action.--
       ``(A) Action if agreement on patent list.--If the 
     subsection (k) applicant and the reference product sponsor 
     agree on patents as described in paragraph (4), not later 
     than 30 days after such agreement, the reference product 
     sponsor shall bring an action for patent infringement with 
     respect to each such patent.
       ``(B) Action if no agreement on patent list.--If the 
     provisions of paragraph (5) apply to the parties as described 
     in paragraph (4)(B), not later than 30 days after the 
     exchange of lists under paragraph (5)(B), the reference 
     product sponsor shall bring an action for patent infringement 
     with respect to each patent that is included on such lists.
       ``(C) Notification and publication of complaint.--
       ``(i) Notification to secretary.--Not later than 30 days 
     after a complaint is served to a subsection (k) applicant in 
     an action for patent infringement described under this 
     paragraph, the subsection (k) applicant shall provide the 
     Secretary with notice and a copy of such complaint.
       ``(ii) Publication by secretary.--The Secretary shall 
     publish in the Federal Register notice of a complaint 
     received under clause (i).
       ``(7) Newly issued or licensed patents.--In the case of a 
     patent that--
       ``(A) is issued to, or exclusively licensed by, the 
     reference product sponsor after the date that the reference 
     product sponsor provided the list to the subsection (k) 
     applicant under paragraph (3)(A); and
       ``(B) the reference product sponsor reasonably believes 
     that, due to the issuance of such patent, a claim of patent 
     infringement could reasonably be asserted by the reference 
     product sponsor if a person not licensed by the reference 
     product sponsor engaged in the making, using, offering to 
     sell, selling, or importing into the United States of the 
     biological product that is the subject of the subsection (k) 
     application,

     not later than 30 days after such issuance or licensing, the 
     reference product sponsor shall provide to the subsection (k) 
     applicant a supplement to the list provided by the reference 
     product sponsor under paragraph (3)(A) that includes such 
     patent, not later than 30 days after such supplement is 
     provided, the subsection (k) applicant shall provide a 
     statement to the reference product sponsor in accordance with 
     paragraph (3)(B), and such patent shall be subject to 
     paragraph (8).
       ``(8) Notice of commercial marketing and preliminary 
     injunction.--
       ``(A) Notice of commercial marketing.--The subsection (k) 
     applicant shall provide notice to the reference product 
     sponsor not later than 180 days before the date of the first 
     commercial marketing of the biological product licensed under 
     subsection (k).
       ``(B) Preliminary injunction.--After receiving the notice 
     under subparagraph (A) and before such date of the first 
     commercial marketing of such biological product, the 
     reference product sponsor may seek a preliminary injunction 
     prohibiting the subsection (k) applicant from engaging in the 
     commercial manufacture or sale of such biological product 
     until the court decides the issue of patent validity, 
     enforcement, and infringement with respect to any patent that 
     is--
       ``(i) included in the list provided by the reference 
     product sponsor under paragraph (3)(A) or in the list 
     provided by the subsection (k) applicant under paragraph 
     (3)(B); and
       ``(ii) not included, as applicable, on--

       ``(I) the list of patents described in paragraph (4); or
       ``(II) the lists of patents described in paragraph (5)(B).

       ``(C) Reasonable cooperation.--If the reference product 
     sponsor has sought a preliminary injunction under 
     subparagraph (B), the reference product sponsor and the 
     subsection (k) applicant shall reasonably cooperate to 
     expedite such further discovery as is needed in connection 
     with the preliminary injunction motion.
       ``(9) Limitation on declaratory judgment action.--
       ``(A) Subsection (k) application provided.--If a subsection 
     (k) applicant provides the application and information 
     required under paragraph (2)(A), neither the reference 
     product sponsor nor the subsection (k) applicant may, prior 
     to the date notice is received under paragraph (8)(A), bring 
     any action under section 2201 of title 28, United States 
     Code, for a declaration of infringement, validity, or 
     enforceability of any patent that is described in clauses (i) 
     and (ii) of paragraph (8)(B).
       ``(B) Subsequent failure to act by subsection (k) 
     applicant.--If a subsection (k) applicant fails to complete 
     an action required of the subsection (k) applicant under 
     paragraph (3)(B)(ii), paragraph (5), paragraph (6)(C)(i), 
     paragraph (7), or paragraph (8)(A), the reference product 
     sponsor, but not the subsection (k) applicant, may bring an 
     action under section 2201 of title 28, United States Code, 
     for a declaration of infringement, validity, or 
     enforceability of any patent included in the list described 
     in paragraph (3)(A), including as provided under paragraph 
     (7).
       ``(C) Subsection (k) application not provided.--If a 
     subsection (k) applicant fails to provide the application and 
     information required under paragraph (2)(A), the reference 
     product sponsor, but not the subsection (k) applicant, may 
     bring an action under section 2201 of title 28, United States 
     Code, for a declaration of infringement, validity, or 
     enforceability of any patent that claims the biological 
     product or a use of the biological product.''.
       (b) Definitions.--Section 351(i) of the Public Health 
     Service Act (42 U.S.C. 262(i)) is amended--
       (1) by striking ``In this section, the term `biological 
     product' means'' and inserting the following: ``In this 
     section:
       ``(1) The term `biological product' means'';
       (2) in paragraph (1), as so designated, by inserting 
     ``protein (except any chemically synthesized polypeptide),'' 
     after ``allergenic product,''; and
       (3) by adding at the end the following:
       ``(2) The term `biosimilar' or `biosimilarity', in 
     reference to a biological product that is the subject of an 
     application under subsection (k), means--

[[Page S13636]]

       ``(A) that the biological product is highly similar to the 
     reference product notwithstanding minor differences in 
     clinically inactive components; and
       ``(B) there are no clinically meaningful differences 
     between the biological product and the reference product in 
     terms of the safety, purity, and potency of the product.
       ``(3) The term `reference product' means the single 
     biological product licensed under subsection (a) against 
     which a biological product is evaluated in an application 
     submitted under subsection (k).
       ``(4) The term `therapeutically equivalent' or `therapeutic 
     equivalence', in reference to a biological product, means 
     that such product has been determined to meet the standards 
     described in subsection (k)(4).''.
       (c) Conforming Amendments Relating to Patents.--
       (1) Patents.--Section 271(e) of title 35, United States 
     Code, is amended--
       (A) in paragraph (2)--
       (i) in subparagraph (A), by striking ``or'' at the end;
       (ii) in subparagraph (B), by adding ``or'' at the end; and
       (iii) by inserting after subparagraph (B) the following:
       ``(C)(i) with respect to a patent that is identified in the 
     list of patents described in section 351(l)(3) of the Public 
     Health Service Act (including as provided under section 
     351(l)(7) of such Act), an application seeking approval of a 
     biological product, or
       ``(ii) if the applicant for the application fails to 
     provide the application and information required under 
     section 351(l)(2)(A) of such Act, an application seeking 
     approval of a biological product for a patent that could be 
     identified pursuant to section 351(l)(3)(A)(i) of such 
     Act,''; and
       (iv) in the matter following subparagraph (C) (as added by 
     clause (iii)), by striking ``or veterinary biological 
     product'' and inserting ``, veterinary biological product, or 
     biological product'';
       (B) in paragraph (4)--
       (i) in subparagraph (B), by--

       (I) striking ``or veterinary biological product'' and 
     inserting ``, veterinary biological product, or biological 
     product''; and
       (II) striking ``and'' at the end;

       (ii) in subparagraph (C), by--

       (I) striking ``or veterinary biological product'' and 
     inserting ``, veterinary biological product, or biological 
     product''; and
       (II) striking the period and inserting ``, and'';

       (iii) by inserting after subparagraph (C) the following:
       ``(D) the court shall order a permanent injunction 
     prohibiting any infringement of the patent by the biological 
     product involved in the infringement until a date which is 
     not earlier than the date of the expiration of the patent 
     that has been infringed under paragraph (2)(C), provided the 
     patent is the subject of a final court decision, as defined 
     in section 351(k)(6) of the Public Health Service Act, in an 
     action for infringement of the patent under section 351(l)(6) 
     of such Act, and the biological product has not yet been 
     approved because of section 351(k)(7) of such Act.''; and
       (iv) in the matter following subparagraph (D) (as added by 
     clause (iii)), by striking ``and (C)'' and inserting ``(C), 
     and (D)''; and
       (C) by adding at the end the following:
       ``(6)(A) Subparagraph (B) applies, in lieu of paragraph 
     (4), in the case of a patent--
       ``(i) that is identified, as applicable, in the list of 
     patents described in section 351(l)(4) of the Public Health 
     Service Act or the lists of patents described in section 
     351(l)(5)(B) of such Act with respect to a biological 
     product; and
       ``(ii) for which an action for infringement of the patent 
     with respect to the biological product--
       ``(I) was brought after the expiration of the 30-day period 
     described in subparagraph (A) or (B), as applicable, of 
     section 351(l)(6) of such Act; or
       ``(II) was brought before the expiration of the 30-day 
     period described in subclause (I), but which was dismissed 
     without prejudice or was not prosecuted to judgment in good 
     faith.
       ``(B) In an action for infringement of a patent described 
     in subparagraph (A), the sole and exclusive remedy that may 
     be granted by a court, upon a finding that the making, using, 
     offering to sell, selling, or importation into the United 
     States of the biological product that is the subject of the 
     action infringed the patent, shall be a reasonable royalty.
       ``(C) The owner of a patent that should have been included 
     in the list described in section 351(l)(3)(A) of the Public 
     Health Service Act, including as provided under section 
     351(l)(7) of such Act for a biological product, but was not 
     timely included in such list, may not bring an action under 
     this section for infringement of the patent with respect to 
     the biological product.''.
       (2) Conforming amendment under title 28.--Section 2201(b) 
     of title 28, United States Code, is amended by inserting 
     before the period the following: ``, or section 351 of the 
     Public Health Service Act''.
       (d) Conforming Amendments Under the Federal Food, Drug, and 
     Cosmetic Act.--
       (1) Content and review of applications.--Section 
     505(b)(5)(B) of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 355(b)(5)(B)) is amended by inserting before the 
     period at the end of the first sentence the following: ``or, 
     with respect to an applicant for approval of a biological 
     product under section 351(k) of the Public Health Service 
     Act, any necessary clinical study or studies''.
       (2) New active ingredient.--Section 505B of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 355c) is amended by 
     adding at the end the following:
       ``(n) New Active Ingredient.--
       ``(1) Non-therapeutically equivalent biosimilar biological 
     product.--A biological product that is biosimilar to a 
     reference product under section 351 of the Public Health 
     Service Act, and that the Secretary has not determined to 
     meet the standards described in subsection (k)(4) of such 
     section for therapeutic equivalence with the reference 
     product, shall be considered to have a new active ingredient 
     under this section.
       ``(2) Therapeutically equivalent biosimilar biological 
     product.--A biological product that is therapeutically 
     equivalent with a reference product under section 351 of the 
     Public Health Service Act shall not be considered to have a 
     new active ingredient under this section.''.
       (e) Products Previously Approved Under Section 505.--
       (1) Requirement to follow section 351.--Except as provided 
     in paragraph (2), an application for a biological product 
     shall be submitted under section 351 of the Public Health 
     Service Act (42 U.S.C. 262) (as amended by this Act).
       (2) Exception.--An application for a biological product may 
     be submitted under section 505 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355) if--
       (A) such biological product is in a product class for which 
     a biological product in such product class is the subject of 
     an application approved under such section 505 not later than 
     the date of enactment of this Act; and
       (B) such application--
       (i) has been submitted to the Secretary of Health and Human 
     Services (referred to in this subtitle as the ``Secretary'') 
     before the date of enactment of this Act; or
       (ii) is submitted to the Secretary not later than the date 
     that is 10 years after the date of enactment of this Act.
       (3) Limitation.--Notwithstanding paragraph (2), an 
     application for a biological product may not be submitted 
     under section 505 of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355) if there is another biological product 
     approved under subsection (a) of section 351 of the Public 
     Health Service Act that could be a reference product with 
     respect to such application (within the meaning of such 
     section 351) if such application were submitted under 
     subsection (k) of such section 351.
       (4) Deemed approved under section 351.--An approved 
     application for a biological product under section 505 of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) shall be 
     deemed to be a license for the biological product under such 
     section 351 on the date that is 10 years after the date of 
     enactment of this Act.
       (5) Definitions.--For purposes of this subsection, the term 
     ``biological product'' has the meaning given such term under 
     section 351 of the Public Health Service Act (42 U.S.C. 262) 
     (as amended by this Act).
       (f) Follow-on Biologics User Fees.--
       (1) Development of user fees for biosimilar biological 
     products.--
       (A) In general.--Beginning not later than October 1, 2010, 
     the Secretary shall develop recommendations to present to 
     Congress with respect to the goals, and plans for meeting the 
     goals, for the process for the review of biosimilar 
     biological product applications submitted under section 
     351(k) of the Public Health Service Act (as added by this 
     Act) for the first 5 fiscal years after fiscal year 2012. In 
     developing such recommendations, the Secretary shall consult 
     with--
       (i) the Committee on Health, Education, Labor, and Pensions 
     of the Senate;
       (ii) the Committee on Energy and Commerce of the House of 
     Representatives;
       (iii) scientific and academic experts;
       (iv) health care professionals;
       (v) representatives of patient and consumer advocacy 
     groups; and
       (vi) the regulated industry.
       (B) Public review of recommendations.--After negotiations 
     with the regulated industry, the Secretary shall--
       (i) present the recommendations developed under 
     subparagraph (A) to the Congressional committees specified in 
     such subparagraph;
       (ii) publish such recommendations in the Federal Register;
       (iii) provide for a period of 30 days for the public to 
     provide written comments on such recommendations;
       (iv) hold a meeting at which the public may present its 
     views on such recommendations; and
       (v) after consideration of such public views and comments, 
     revise such recommendations as necessary.
       (C) Transmittal of recommendations.--Not later than January 
     15, 2012, the Secretary shall transmit to Congress the 
     revised recommendations under subparagraph (B), a summary of 
     the views and comments received under such subparagraph, and 
     any changes made to the recommendations in response to such 
     views and comments.
       (2) Establishment of user fee program.--It is the sense of 
     the Senate that, based on the recommendations transmitted to 
     Congress by the Secretary pursuant to paragraph (1)(C), 
     Congress should authorize a program, effective on October 1, 
     2012, for the collection of user fees relating to the 
     submission of biosimilar biological product applications 
     under section 351(k) of the Public Health Service Act (as 
     added by this Act).

[[Page S13637]]

       (3) Transitional provisions for user fees for biosimilar 
     biological products.--
       (A) Application of the prescription drug user fee 
     provisions.--Section 735(1)(B) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 379g(1)(B)) is amended by striking 
     ``section 351'' and inserting ``subsection (a) or (k) of 
     section 351''.
       (B) Evaluation of costs of reviewing biosimilar biological 
     product applications.--During the period beginning on the 
     date of enactment of this Act and ending on October 1, 2010, 
     the Secretary shall collect and evaluate data regarding the 
     costs of reviewing applications for biological products 
     submitted under section 351(k) of the Public Health Service 
     Act (as added by this Act) during such period.
       (C) Audit.--
       (i) In general.--On the date that is 2 years after first 
     receiving a user fee applicable to an application for a 
     biological product under section 351(k) of the Public Health 
     Service Act (as added by this Act), and on a biennial basis 
     thereafter until October 1, 2013, the Secretary shall perform 
     an audit of the costs of reviewing such applications under 
     such section 351(k). Such an audit shall compare--

       (I) the costs of reviewing such applications under such 
     section 351(k) to the amount of the user fee applicable to 
     such applications; and
       (II)(aa) such ratio determined under subclause (I); to
       (bb) the ratio of the costs of reviewing applications for 
     biological products under section 351(a) of such Act (as 
     amended by this Act) to the amount of the user fee applicable 
     to such applications under such section 351(a).

       (ii) Alteration of user fee.--If the audit performed under 
     clause (i) indicates that the ratios compared under subclause 
     (II) of such clause differ by more than 5 percent, then the 
     Secretary shall alter the user fee applicable to applications 
     submitted under such section 351(k) to more appropriately 
     account for the costs of reviewing such applications.
       (iii) Accounting standards.--The Secretary shall perform an 
     audit under clause (i) in conformance with the accounting 
     principles, standards, and requirements prescribed by the 
     Comptroller General of the United States under section 3511 
     of title 31, United State Code, to ensure the validity of any 
     potential variability.
       (4) Authorization of appropriations.--There is authorized 
     to be appropriated to carry out this subsection such sums as 
     may be necessary for each of fiscal years 2010 through 2012.
       (g) Pediatric Studies of Biological Products.--
       (1) In general.--Section 351 of the Public Health Service 
     Act (42 U.S.C. 262) is amended by adding at the end the 
     following:
       ``(m) Pediatric Studies.--
       ``(1) Application of certain provisions.--The provisions of 
     subsections (a), (d), (e), (f), (i), (j), (k), (l), (p), and 
     (q) of section 505A of the Federal Food, Drug, and Cosmetic 
     Act shall apply with respect to the extension of a period 
     under paragraphs (2) and (3) to the same extent and in the 
     same manner as such provisions apply with respect to the 
     extension of a period under subsection (b) or (c) of section 
     505A of the Federal Food, Drug, and Cosmetic Act.
       ``(2) Market exclusivity for new biological products.--If, 
     prior to approval of an application that is submitted under 
     subsection (a), the Secretary determines that information 
     relating to the use of a new biological product in the 
     pediatric population may produce health benefits in that 
     population, the Secretary makes a written request for 
     pediatric studies (which shall include a timeframe for 
     completing such studies), the applicant agrees to the 
     request, such studies are completed using appropriate 
     formulations for each age group for which the study is 
     requested within any such timeframe, and the reports thereof 
     are submitted and accepted in accordance with section 
     505A(d)(3) of the Federal Food, Drug, and Cosmetic Act--
       ``(A) the periods for such biological product referred to 
     in subsection (k)(7)(B) are deemed to be 4 years and 6 months 
     rather than 4 years and the date that is 6 months after the 
     date described in subsection (k)(7)(A) rather than the date 
     described in such subsection; and; and
       ``(B) if the biological product is designated under section 
     526 for a rare disease or condition, the period for such 
     biological product referred to in section 527(a) is deemed to 
     be 7 years and 6 months rather than 7 years.
       ``(3) Market exclusivity for already-marketed biological 
     products.--If the Secretary determines that information 
     relating to the use of a licensed biological product in the 
     pediatric population may produce health benefits in that 
     population and makes a written request to the holder of an 
     approved application under subsection (a) for pediatric 
     studies (which shall include a timeframe for completing such 
     studies), the holder agrees to the request, such studies are 
     completed using appropriate formulations for each age group 
     for which the study is requested within any such timeframe, 
     and the reports thereof are submitted and accepted in 
     accordance with section 505A(d)(3) of the Federal Food, Drug, 
     and Cosmetic Act--
       ``(A) the periods for such biological product referred to 
     in subsection (k)(7)(B) are deemed to be 4 years and 6 months 
     rather than 4 years and the date that is 6 months after the 
     date described in subsection (k)(7)(A) rather than the date 
     described in such subsection; and
       ``(B) if the biological product is designated under section 
     526 for a rare disease or condition, the period for such 
     biological product referred to in section 527(a) is deemed to 
     be 7 years and 6 months rather than 7 years.
       ``(4) Exception.--The Secretary shall not extend a period 
     referred to in paragraph (2)(A), (2)(B), (3)(A), or (3)(B) if 
     the determination under section 505A(d)(3) is made later than 
     9 months prior to the expiration of such period.''.
       (2) Studies regarding pediatric research.--
       (A) Program for pediatric study of drugs.--Subsection 
     (a)(1) of section 409I of the Public Health Service Act (42 
     U.S.C. 284m) is amended by inserting ``, biological 
     products,'' after ``including drugs''.
       (B) Institute of medicine study.--Section 505A(p) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355b(p)) is 
     amended by striking paragraphs (4) and (5) and inserting the 
     following:
       ``(4) review and assess the number and importance of 
     biological products for children that are being tested as a 
     result of the amendments made by the Patient Access to Safe 
     and Competitive Biologics Act and the importance for 
     children, health care providers, parents, and others of 
     labeling changes made as a result of such testing;
       ``(5) review and assess the number, importance, and 
     prioritization of any biological products that are not being 
     tested for pediatric use; and
       ``(6) offer recommendations for ensuring pediatric testing 
     of biological products, including consideration of any 
     incentives, such as those provided under this section or 
     section 351(m) of the Public Health Service Act.''.
       (h) Orphan Products.--If a reference product, as defined in 
     section 351 of the Public Health Service Act (42 U.S.C. 262) 
     (as amended by this Act) has been designated under section 
     526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     360bb) for a rare disease or condition, a biological product 
     seeking approval for such disease or condition under 
     subsection (k) of such section 351 as biosimilar or 
     therapeutically equivalent to, such reference product may be 
     licensed by the Secretary only after the expiration for such 
     reference product of the later of--
       (1) the 7-year period described in section 527(a) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360cc(a)); 
     and
       (2) the period of exclusivity described in subsection 
     (k)(7)(A) of such section 351.

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