[Congressional Record Volume 153, Number 29 (Thursday, February 15, 2007)]
[Senate]
[Pages S2053-S2057]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. SCHUMER (for himself, Mrs. Clinton, Mr. Vitter, Ms. 
        Collins, Mr. Leahy, and Ms. Stabenow):
  S. 623. A bill to amend the Public Health Service Act to provide for 
the licensing of comparable and interchangeable biological products, 
and for other purposes; to the Committee on Health, Education, Labor, 
and Pensions.
  Mr. SCHUMER. Mr. President, I rise today to introduce the Access to 
Life-Saving Medicine Act with my colleague, Senator Clinton. 
Recognizing the promise of generic drugs as safe and effective 
treatments at greatly reduced prices, I have worked for years with my 
colleagues in the House and the Senate to increase generic drug 
availability and accessibility, most notably with Senator McCain on a 
2003 law. This legislation represents the next step in the availability 
of generic drugs for American consumers by creating a statutory pathway 
for generic

[[Page S2054]]

versions of biotech drugs to enter the market.
  While generic drugs save American consumers an estimated eight to ten 
billion dollars each year, American consumers have not yet reaped the 
full potential savings from the generic drug market. Under current law, 
there is no generic approval process at the Food and Drug 
Administration, FDA, for an entire category of drugs, even once the 
patents have expired. These biologic drugs, which are an expensive and 
growing sector of the pharmaceutical market, will obtain monopoly 
pricing on the market indefinitely without the possibility of generic 
competitors.
  Drug companies that invest in the research and development of life-
saving drugs, whether biological or chemical in nature, deserve to be 
rewarded for their work. At the same time, patients need the ability to 
access affordable drugs. We have created a statutory framework for 
chemical drugs that balances incentives for continued innovations with 
access to affordable drugs for patients. But, this framework has not 
yet expanded to biotech drugs, which are on the cutting edge of science 
but for which the laws are hopelessly out of date.
  Now is the time to ensure that American consumers have the same 
access to life-saving biotech drugs that consumers have to well-known, 
widely used chemical drugs. Patients need to be able to afford and 
access their medications, and they don't care what kind of drug they 
have. Patients rely on biotech drugs to treat a wide array of diseases, 
ranging from diabetes to cancer to AIDS, but with no generic versions 
of biotech drugs available, these drugs can cost tens of thousands of 
dollars a year--too expensive for many patients to afford. Introducing 
fair competition for biotech drugs is essential to make life-saving 
biotech treatments affordable.
  The Access to Life-Saving Medicine Act will allow the FDA to approve 
generic versions of biologic drugs that have been determined to be both 
safe and effective. The FDA is not required to approve any generic 
biologics, but if the data is there, they will now have the ability to 
do so.
  A report released earlier this year by Pharmaceutical Care Management 
Association estimated that the introduction of generic biotech drugs 
into the market could save Medicare Part B $14 billion over the next 
ten years. We need to embrace those potential savings and provide 
American consumers access to affordable biotech drugs.
  Moving this legislation forward and creating a statutory pathway for 
generic versions of biotech drugs to enter the market is one of my 
highest priorities in the 110th Congress. I look forward to working 
with my colleagues, especially Senator Clinton, to accomplish this 
goal.
  Mr. President, I ask unanimous consent that the text of the bill be 
printed in the Record.
  Ms. CLINTON. Mr. President, I am pleased today to join with Senator 
Schumer to introduce the Access of Life-Saving Medicine Act. This 
legislation will have a dramatic impact on the rising costs of 
prescription drugs, which puts the squeeze on employers trying to 
provide health coverage for employees while turning a profit, on 
families struggling to make ends meet, and on our economy. We spend 16 
percent of our national income on health care and prescription drugs 
and that number is on the climb.
  In 2005, the cost of biologics grew 17.5 percent compared to the cost 
of traditional drugs, which increased 10 percent. According to CMS, the 
top 2 anemia drugs--both biologics--accounted for 17 percent of all 
Medicare Part B carrier drug spending, while two other biologics for 
rheumatoid arthritis and cancer accounted for an additional 13 percent. 
In 2006, the Medicare Part B program spent more than $5 billion on 
biologic drugs.
  More than $10 billion worth of biopharmaceuticals will come off 
patent in the next 5 years but will continue to cost on-patent prices 
unless we act. Our legislation creates a pipeline for approval of safe, 
cost effective generic versions of these biologic drugs. Without 
action, the manufacturers of these biotech drugs can continue to charge 
monopoly prices indefinitely.
  This is a perfect example of skyrocketing costs in health care--and a 
perfect opportunity to put the brakes on this overspending, which is 
bad for patients, businesses, and our country.
  According to a report released in January by Engel & Novitt to the 
Pharmaceutical Care Management Association, passage of this bill could 
save, by conservative estimates, $14 billion over the next 10 years in 
Medicare Part B alone.
  Scientific advances over the past 20 years have made the 
biotechnology industry an integral part of the pharmaceutical industry, 
but our health care system has not kept pace. Our laws need to be 
updated to reflect the critical role biologics now play in treatment.
  The Access to Life-Saving Medicine Act amends the Public Health 
Service Act to authorize the FDA to approve abbreviated applications 
for biological products that are ``comparable'' to and 
``interchangeable'' with previously approved biological products. And 
because biological products are very diverse, the Secretary has 
discretion on a case-by-case basis to determine what studies are 
necessary to establish comparability and interchangeability, and may 
require a clinical study or studies if necessary.
  To encourage the development of substitutable products, the 
legislation gives the first applicant to obtain approval of an 
interchangeable product a period of exclusive marketing during which no 
other interchangeable version of the product may be approved. In order 
to facilitate timely access to these products, an approval may, 
however, be granted for a comparable version of the brand name product 
if it is not interchangeable.
  Finally, to encourage early resolution of patent disputes which might 
otherwise delay competition, a patent holder must disclose relevant 
patents in response to a request and bring a patent infringement suit 
within 45 days of notice of a challenge or lose the right to certain 
remedies in court.
  Biotech drugs hold great promise, but we break that promise when 
costs push treatment out of reach for American families and employers. 
We should bring safe, effective and affordable generic versions of 
these medicines to patients through passage of the Access to Life-
Saving Medicine Act, saving money and lives.
  This issue is part of a larger challenge. It is time to develop a 
health care system that reflects and responds to how people are living 
today, that addresses the critical problems in cost, quality, and 
coverage.
  We can use what is right in health care--incredible ingenuity, 
leaders at the forefront of medical research, advances in technology, 
the best medical professionals in the world--to fix what is wrong.
  Smart solutions to the vexing problems plaguing our health care 
system will require evidence-based--not ideologically-based--decision 
making.
  My wonderful predecessor, Senator Moynihan, memorably said, 
``Everyone is entitled to his own opinion, but no one is entitled to 
his own facts.'' Well, right now, we see a lot of people who have their 
own facts that are not based on the evidence.
  The fact is, building a pipeline for generic biologics is long 
overdue. Achieving this goal is a top priority for me in the HELP 
Committee when we consider FDA-related legislation this spring and I 
look forward to working with Senator Schumer and my other colleagues to 
get it done.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                 S. 623

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Access to Life-Saving 
     Medicine Act''.

     SEC. 2. DEFINITIONS.

       (a) Amendments.--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''; and
       (2) by adding at the end the following:
       ``(2) The term `abbreviated biological product application' 
     means an abbreviated application for a license of a 
     biological product containing the same, or similar, active 
     ingredient as a reference product.
       ``(3) The term `reference product' means the single 
     licensed biological product, approved under subsection (a) or 
     subsection

[[Page S2055]]

     (k), against which a biological product is evaluated for 
     demonstration of safety, potency, or purity.
       ``(4) The term `comparable' or `comparability' in reference 
     to a biological product means the absence of clinically 
     meaningful differences between the biological product and the 
     reference product in terms of the safety, purity, and potency 
     of the product based upon--
       ``(A) data derived from chemical, physical, and biological 
     assays, and other non-clinical laboratory studies; and
       ``(B) data from any necessary clinical study or studies 
     sufficient to confirm safety, purity, and potency in one or 
     more appropriate conditions of use for which the reference 
     product is licensed and intended to be used.

     Any studies under subparagraph (B) shall be designed to avoid 
     duplicative and unethical clinical testing.
       ``(5) The terms `interchangeable' and `interchangeability' 
     mean, with respect to the condition of use involved, that the 
     biological product--
       ``(A) is comparable to the reference product; and
       ``(B) can be expected to produce the same clinical result 
     as the reference product in any given patient.
       ``(6) The term `thorough characterization' means an 
     analysis of structural features based upon appropriate 
     analytical and functional testing sufficient to identify 
     differences between a biological product and reference 
     product relevant to safety, purity or potency.
       ``(7) The term `final action' means, with respect to an 
     abbreviated biological product application, the Secretary's 
     issuance of a final action letter to the sponsor of an 
     abbreviated biological product application which--
       ``(A) approves the application; or
       ``(B) disapproves the application and sets forth in detail 
     an enumeration of the specific deficiencies in the particular 
     application and of the specific, enumerated actions the 
     sponsor would be required to take in order for the sponsor to 
     receive a final action letter that approves such application.
       ``(8) The term `final action date' means, with respect to 
     an abbreviated biological product application, the date by 
     which the Secretary must take a final action on the 
     application pursuant to subsection (k)(11).
       ``(9) The term `reviewing division' means the division 
     responsible for the review of an application for approval of 
     a biological product (including all scientific and medical 
     matters, chemistry, manufacturing, and controls).''.
       (b) Rule of Construction.--Nothing in this Act or the 
     amendments made by this Act shall be construed to exclude an 
     application for licensure of a biological product under 
     section 351(k) from the definition of a human drug 
     application in section 735(1)(C) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 379g(1)(C)).

     SEC. 3. REGULATION OF COMPARABLE AND INTERCHANGEABLE 
                   BIOLOGICAL PRODUCTS.

       (a) In General.--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 subsection:
       ``(k) Regulation of Comparable and Interchangeable 
     Biological Products.--
       ``(1) Submission of an abbreviated biological product 
     application.--Any person may file with the Secretary an 
     abbreviated biological product application. Any such 
     application shall include the following:
       ``(A) Data demonstrating that the biological product is 
     comparable to or interchangeable with the reference product.
       ``(B) Data demonstrating that the biological product and 
     reference product contain highly similar principal molecular 
     structural features, notwithstanding minor differences in 
     heterogeneity profile, impurities, or degradation patterns. 
     The Secretary shall find the following types of products to 
     contain highly similar principal molecular structural 
     features:
       ``(i) Two protein biological products with differences in 
     structure between them solely due to post-translational 
     events, infidelity of translation or transcription, or minor 
     differences in amino acid sequence.
       ``(ii) Two polysaccharide biological products with similar 
     saccharide repeating units, even if the number of units 
     differ and even if there are differences in post-
     polymerization modifications.
       ``(iii) Two glycosylated protein products with differences 
     in structure between them solely due to post-translational 
     events, infidelity of translation or transcription, or minor 
     differences in amino acid sequence, and if they had similar 
     saccharide repeating units, even if the number of units 
     differ and even if there were differences in post-
     polymerization modifications.
       ``(iv) Two polynucleotide biological products with 
     identical sequence of purine and pyrimidine bases (or their 
     derivatives) bound to an identical sugar backbone (ribose, 
     deoxyribose, or modifications of these sugars).
       ``(v) Closely related, complex partly definable biological 
     products with similar therapeutic intent, such as two live 
     viral products for the same indication.

     Two biological products not enumerated in the foregoing 
     clauses may be demonstrated to contain highly similar 
     principal molecular structural features based upon such data 
     and other information characterizing the two products as the 
     Secretary determines to be necessary.
       ``(C) Data demonstrating that 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.
       ``(D) Information to show that 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.
       ``(E) Information to show that the route of administration, 
     the dosage form, and the strength of the biological product 
     are the same as those of the reference product.
       ``(F) Data demonstrating that 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.
       ``(G) At the applicant's option, publicly-available 
     information regarding the Secretary's previous determination 
     that the reference product is safe, pure, and potent.
       ``(H) Any additional data and information in support of the 
     application, including publicly-available information with 
     respect to the reference product or another biological 
     product.
       ``(2) Other applications.--Any person, including a person 
     who has not conducted and does not have a right of reference 
     to the studies in the application for a reference product, 
     may submit an application under this paragraph for a 
     biological product that differs from, or incorporates a 
     change to, the reference product with respect to one or more 
     characteristics described in subparagraphs (A) through (E) of 
     paragraph (1), including a difference in safety, purity, or 
     potency, so long as the application contains sufficient 
     information to establish the safety, purity, and potency of 
     the biological product relative to the reference product for 
     its proposed condition or conditions of use.
       ``(3) FDA review of abbreviated biological product 
     applications.--
       ``(A) Guidance regarding review of applications.--The 
     Secretary shall issue guidance for the individuals who review 
     applications submitted under paragraph (1) or (2), which 
     shall relate to promptness in conducting the review, 
     technical excellence, lack of bias and conflict of interest, 
     and knowledge of regulatory and scientific standards, and 
     which shall apply equally to all individuals who review such 
     applications.
       ``(B) Meetings with sponsors and applicants.--The Secretary 
     shall meet with a sponsor of an investigation or an applicant 
     for approval of a comparable or interchangeable biological 
     product under this subsection if the sponsor or applicant 
     makes a reasonable written request for a meeting for the 
     purpose of reaching agreement on the design and size of 
     studies needed for approval of the application. The sponsor 
     or applicant shall provide information necessary for 
     discussion and agreement on the design and size of such 
     studies. Minutes of any such meeting shall be prepared by the 
     Secretary and made available to the sponsor or applicant.
       ``(C) Agreements.--Any agreement regarding the parameters 
     of design and size of the studies of a biological product 
     under this paragraph that is reached between the Secretary 
     and a sponsor or applicant shall be reduced to writing and 
     made part of the administrative record by the Secretary. Such 
     agreement shall not be changed after the testing begins, 
     except--
       ``(i) with the written agreement of the sponsor or 
     applicant; or
       ``(ii) pursuant to a decision, made in accordance with 
     subparagraph (D) by the director of the reviewing division, 
     that a substantial scientific issue essential to determining 
     the safety, purity, and potency of the biological product has 
     been identified after the testing has begun.
       ``(D) Procedure regarding certain decisions.--A decision 
     under subparagraph (C)(ii) by the director shall be in 
     writing and the Secretary shall provide to the sponsor or 
     applicant an opportunity for a meeting at which the director 
     and the sponsor or applicant will be present and at which the 
     director will document the scientific issue involved.
       ``(E) Effect of decisions.--The written decisions of the 
     reviewing division shall be binding upon, and may not 
     directly or indirectly be changed by, the field or compliance 
     office personnel unless such field or compliance office 
     personnel demonstrate to the reviewing division why such 
     decision should be modified.
       ``(F) Delays by reviewing divisions.--No action by the 
     reviewing division may be delayed because of the 
     unavailability of information from or action by field 
     personnel unless the reviewing division determines that a 
     delay is necessary to assure the marketing of a safe, pure, 
     and potent biological product.
       ``(4) Approval of comparable or interchangeable biological 
     products.--
       ``(A) Determination of comparability.--Upon review of an 
     application submitted under paragraph (1) or (2) for a 
     biological

[[Page S2056]]

     product, the Secretary shall issue a comparable biological 
     product license for all conditions of use of the reference 
     product sharing the same mechanism or mechanisms of action 
     for which the applicant has demonstrated comparability for a 
     single condition of use, or, if the mechanism or mechanisms 
     of action are unknown, for the condition or conditions of use 
     for which the data submitted establishes comparability, 
     unless the Secretary finds and informs the applicant that--
       ``(i) information submitted in the application or any other 
     information available to the Secretary is insufficient to 
     show that the biological product is comparable to the 
     reference product for the condition or conditions of use 
     prescribed, recommended, or suggested in the labeling 
     proposed in the application;
       ``(ii) information submitted in the application or any 
     other information available to the Secretary is insufficient 
     to show that the biological product and the reference product 
     contain highly similar principal molecular structural 
     features, notwithstanding minor differences in heterogeneity 
     profile, impurities, or degradation patterns;
       ``(iii) information submitted in the application or any 
     other information available to the Secretary is insufficient 
     to show that the biological product and reference product 
     utilize the same mechanism or mechanisms of action for the 
     conditions of use prescribed, recommended, or suggested in 
     the labeling proposed for the biological product, unless the 
     mechanism or mechanisms of action are not known for the 
     reference product for such condition or conditions;
       ``(iv) information submitted in the application or any 
     other information available to the Secretary is insufficient 
     to show that the route of administration, the dosage form, 
     and the strength of the biological product are the same as 
     those of the reference product;
       ``(v) information submitted in the application or any other 
     information available to the Secretary is insufficient to 
     show that the condition or conditions of use prescribed, 
     recommended, or suggested in the labeling proposed for the 
     biological product are limited to one or more of the same use 
     or uses as have been previously approved for the reference 
     product;
       ``(vi) information submitted in the application or any 
     other information available to the Secretary shows (I) the 
     inactive ingredients of the biological product are unsafe for 
     use under the conditions prescribed, recommended, or 
     suggested in the labeling proposed for the biological 
     product, or (II) the composition of the biological product is 
     unsafe under such conditions because of the type or quantity 
     of inactive ingredients included or the manner in which the 
     inactive ingredients are included;
       ``(vii) information submitted in the application or any 
     other information available to the Secretary fails to 
     demonstrate that 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;
       ``(viii) the Secretary has withdrawn or suspended the 
     license of the reference product, for safety or effectiveness 
     reasons, or has published a notice of opportunity for hearing 
     to withdraw such license for safety or effectiveness reasons, 
     or the Secretary has determined that the reference product 
     has been withdrawn from sale for safety or effectiveness 
     reasons; or
       ``(ix) the application contains an untrue statement of 
     material fact; and
     provides the applicant with a detailed explanation for the 
     decision.
       ``(B) Determinations on interchangeability.--Subject to 
     subparagraph (C) and paragraph (10), upon issuing a product 
     license for a biological product under subparagraph (A), the 
     Secretary shall make and publish one of the following 
     determinations:
       ``(i) Such product is interchangeable with the reference 
     product for one or more specified conditions of use 
     prescribed, recommended, or suggested in the labeling of the 
     biological product.
       ``(ii) Interchangeability has not been established.
       ``(C) Determination of interchangeability of subsequent 
     biological product.--If the Secretary determines that an 
     application meets the approval requirements of subparagraph 
     (A), and, prior to the issuance of a product license, the 
     Secretary has made a determination of interchangeability of 
     another biological product and the reference product for 
     which the exclusivity period under paragraph (10) has not 
     expired, the Secretary shall--
       ``(i) issue the product license for the subsequent 
     biological product; and
       ``(ii) defer issuing any determination of 
     interchangeability as to the subsequent biological product 
     and the reference product until the exclusivity period under 
     paragraph (10) has expired.
       ``(5) Postmarketing studies for applications submitted 
     under paragraph (1).--If the Secretary has agreed with the 
     sponsor of the reference product, at the time of approval or 
     any time thereafter, that the sponsor shall conduct one or 
     more postmarketing safety studies, a person submitting an 
     application for a biological product under paragraph (1) may 
     agree with the Secretary to conduct a similar postmarketing 
     safety study or studies upon a reasonable showing that such 
     study or studies would provide relevant information not 
     available from the studies on the reference product. The 
     Secretary shall not, as a condition of approval, propose any 
     additional postmarketing studies for such biological product.
       ``(6) Designation of official name.--If, pursuant to 
     section 508 of the Federal Food, Drug, and Cosmetic Act, the 
     Secretary determines that designation of an official name for 
     a comparable biological product is necessary or desirable in 
     the interests of usefulness or simplicity, the Secretary 
     shall designate the same official name for the comparable 
     biological product as the Secretary designated for the 
     reference product. This paragraph shall not apply to products 
     approved under paragraph (7).
       ``(7) Other approval provisions.--The Secretary shall 
     approve, under the provisions of paragraph (4)(A), an 
     application for a license submitted under paragraph (2), 
     except that the Secretary shall approve such an application 
     that would otherwise be disapproved by reason of one or more 
     of subparagraphs (A) through (E) of paragraph (4)(A), if the 
     application and any other information available to the 
     Secretary are sufficient to establish the safety, purity, and 
     potency of the comparable biological product relative to the 
     reference product for the proposed condition or conditions of 
     use for such product.
       ``(8) Establishing interchangeability for comparable 
     biological products.--
       ``(A) In general.--In an original application or a 
     supplement to an application under this subsection, an 
     applicant may submit information to the Secretary to 
     demonstrate the interchangeability of a comparable biological 
     product and the reference product. An applicant may withdraw 
     an interchangeability submission at any time. A request for 
     an interchangeability determination submitted after the 
     filing of an application shall be considered a major 
     amendment to the application. Nothing in this subsection 
     shall be construed to prohibit the Secretary from making a 
     determination of interchangeability at any time after 
     approval.
       ``(B) Guidance.--Within one year after enactment of the 
     Access to Life-Saving Medicine Act, the Secretary shall issue 
     guidance regarding standards and requirements for 
     interchangeability. The Secretary may make determinations of 
     interchangeability under paragraph (4)(B) prior to issuing 
     guidance under this subparagraph.
       ``(9) Interchangeability labeling for comparable biological 
     products.--Upon a determination of interchangeability, the 
     Secretary, if requested by the applicant, shall provide for 
     the label of the comparable biological product to include a 
     statement that the biological product is interchangeable with 
     the reference product for the conditions of use prescribed, 
     recommended, or suggested in the labeling for which 
     interchangeability has been established.
       ``(10) Exclusivity.--
       ``(A) In general.--Upon review of an abbreviated biological 
     product application relying on the same reference product for 
     which a prior biological product has received a determination 
     of interchangeability for any condition of use, the Secretary 
     shall not make a determination under paragraph (4)(B) that 
     the second or subsequent biological product is 
     interchangeable for any condition of use, and no holder of a 
     biological product license approved under subsection (a) 
     shall manufacture, market, sell, or distribute a rebranded 
     interchangeable biological product, directly or indirectly, 
     or authorize any other person to manufacture, market, sell, 
     or distribute a rebranded interchangeable biological product, 
     for any condition of use, until the earlier of--
       ``(i) 180 days after the first commercial marketing of the 
     first interchangeable comparable biological product to be 
     approved as interchangeable for that reference product;
       ``(ii) one year after--

       ``(I) a final court decision on all patents in suit in an 
     action instituted under paragraph (17)(C) against the 
     applicant that submitted the application for the first 
     approved interchangeable comparable biological product; or
       ``(II) the dismissal with or without prejudice of an action 
     instituted under paragraph (17)(C) against the applicant that 
     submitted the application for the first approved 
     interchangeable comparable biological product; or

       ``(iii)(I) 36 months after approval of the first 
     interchangeable comparable biological product if the 
     applicant has been sued under paragraph (17)(C) and such 
     litigation is still ongoing within such 36-month period; or
       ``(II) one year after approval in the event that the first 
     approved interchangeable comparable applicant has not been 
     sued under paragraph (17)(C).

     For purposes of this subparagraph, 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.
       ``(B) Rebranded interchangeable biological product.--For 
     purposes of this subsection, the term `rebranded 
     interchangeable biological product'--
       ``(i) means any rebranded interchangeable version of the 
     reference product involved that the holder of the biological 
     product license approved under subsection (a) for that 
     reference product seeks to commence marketing, selling, or 
     distributing, directly or indirectly; and
       ``(ii) does not include any product to be marketed, sold, 
     or distributed--

[[Page S2057]]

       ``(I) by an entity eligible for exclusivity with respect to 
     such product under this paragraph; or
       ``(II) after expiration of any exclusivity with respect to 
     such product under this paragraph.

       ``(11) Hearing.--If the Secretary decides to disapprove an 
     abbreviated biological product application, the Secretary 
     shall give the applicant notice of an opportunity for a 
     hearing before the Secretary on the question of whether such 
     application is approvable. If the applicant elects to accept 
     the opportunity for hearing by written request within thirty 
     days after such notice, such hearing shall commence not more 
     than ninety days after the expiration of such thirty days 
     unless the Secretary and the applicant otherwise agree. Any 
     such hearing shall thereafter be conducted on an expedited 
     basis, and the Secretary's order thereon shall be issued 
     within ninety days after the date fixed by the Secretary for 
     filing final briefs.
       ``(12) Final action date.--
       ``(A) In general.--The Secretary shall take a final action 
     on an abbreviated biological product application by the date 
     that is 8 calendar months following the sponsor's submission 
     of such application, or 180 days following the Secretary's 
     notification to the applicant that its application has been 
     accepted for filing, whichever is earlier.
       ``(B) Extension.--The final action date provided by 
     subparagraph (A) with respect to an application may be 
     extended for such period of time as is agreed to by the 
     Secretary and the applicant in a jointly executed written 
     agreement that is counter-signed by the Secretary and the 
     applicant no later than 30 days prior to such date.
       ``(13) Request for delay of final action.--Notwithstanding 
     paragraph (18) or any other provision of law, the Secretary 
     shall not fail or refuse to take a final action on an 
     abbreviated biological product application by the final 
     action date on the basis that a person, other than the 
     comparable biological product applicant, has requested (in a 
     petition or otherwise) that the Secretary refuse to take or 
     otherwise defer such final action, and no court shall enjoin 
     the Secretary from taking final action or stay the effect of 
     final action previously taken by the Secretary, except by 
     issuance of a permanent injunction based upon an express 
     finding of clear and convincing evidence that the person 
     seeking to have the Secretary refuse to take or otherwise to 
     defer final action by the final action date--
       ``(A) has prevailed on the merits of the person's complaint 
     against the Secretary;
       ``(B) will suffer imminent and actual irreparable injury, 
     constituting more than irrecoverable economic loss, and that 
     also will threaten imminent destruction of such person's 
     business; and
       ``(C) has an interest that outweighs the overwhelming 
     interest that the public has in obtaining prompt access to a 
     comparable biological product.
       ``(14) Report on extensions of final action date.--The 
     Secretary shall prepare and submit to the President, the 
     Committee on Energy and Commerce of the House of 
     Representatives, and the Committee on Health, Education, 
     Labor, and Pensions of the Senate a report regarding any 
     jointly executed written agreement to extend the final action 
     date under this Act within 15 calendar days after the joint 
     execution of any such written agreement.
       ``(15) Report on failure to take final action.--The 
     Secretary shall prepare and submit annually to the President, 
     the Committee on Energy and Commerce of the House of 
     Representatives, and the Committee on Health, Education, 
     Labor, and Pensions of the Senate a report detailing the 
     specific and particularized reasons enumerated by the 
     reviewing division for each instance of the Secretary's 
     failure to take final action by the final action date in the 
     previous year.
       ``(16) Regulations.--The Secretary shall establish, by 
     regulation within 2 years after the date of the enactment of 
     this subsection, requirements for the efficient review, 
     approval, suspension, and revocation of abbreviated 
     biological product applications under this subsection.
       ``(17) Patents.--
       ``(A) Request for patent information.--
       ``(i) In general.--At any time, including at the initial 
     stages of development, an applicant or a prospective 
     applicant under this subsection may send a written request 
     for patent information to the holder of the approved 
     application for the reference product. The holder of the 
     approved application for the reference product shall, not 
     later than 60 days after the date on which the holder 
     receives the request, provide to the applicant or prospective 
     applicant a list of all those patents owned by, or licensed 
     to, the holder of the approved application that the holder 
     believes in good faith relate to the reference product, 
     including patents that claim the approved biological product, 
     any method of using such product, any component of such 
     product, or any method or process of manufacturing such 
     product or component.
       ``(ii) Costs of complying with request.--The application 
     holder may demand payment of not more than $1,000 to offset 
     the cost of responding to the request for information.
       ``(iii) Updates.--For a period of two years beginning on 
     the date on which the holder of the approved application for 
     the reference product receives the request for information, 
     the holder shall send to the applicant or prospective 
     applicant updates of its response to the request for 
     information by identifying all relevant patents issued or 
     licensed to the holder after the initial response under 
     clause (i). Any such update must be provided, in the case of 
     a new patent, not later than 30 days after the date on which 
     the patent is issued and, in the case of a license, not later 
     than 30 days after the date on which the holder obtains the 
     license.
       ``(iv) Additional requests.--The applicant may submit 
     additional requests for patent information, subject to the 
     requirements of this paragraph, at any time.
       ``(B) Patent notifications.--At any time after submitting 
     an application under this subsection, the applicant may 
     provide a notice of the application with respect to any one 
     or more patents identified by the holder of the reference 
     product pursuant to subparagraph (A). An applicant may submit 
     additional notices at any time, and each notice shall be 
     subject to the provisions of this subparagraph. Each notice 
     shall--
       ``(i) be sent to the holder of the approved application for 
     the reference product and to the owner of any patent 
     identified by the holder pursuant to subparagraph (A);
       ``(ii) include a detailed statement of the factual and 
     legal bases for the applicant's belief that the patents 
     included in the notice are invalid, are unenforceable, or 
     will not be infringed by the commercial sale of the product 
     for which approval is being sought under this subsection; and
       ``(iii) identify 1 or more judicial districts in which the 
     applicant consents to such suit being brought.
       ``(C) Action for infringement.--Within 45 days after the 
     date on which the holder of the approved application for the 
     reference product, or the owner of a patent, receives a 
     notice under subparagraph (B), the holder or patent owner may 
     bring an action for infringement only with respect to the 
     patent or patents included in the notice, and only in a 
     judicial district identified pursuant to subparagraph 
     (B)(iii).
       ``(D) Limitation on declaratory judgment actions.--With 
     respect to any patent relating to a product that is the 
     subject of an application under this subsection, the 
     recipient of a notice under subparagraph (B) with respect to 
     that application may not, prior to the commercial marketing 
     of the product, bring any action under section 2201 of title 
     28, United States Code, for a declaration of infringement, 
     validity, or enforceability of any such patent that was not 
     identified in the notice. With respect to any such patent 
     identified in the notice, any such action may, 
     notwithstanding chapter 87 of title 28, United States Code, 
     be brought only in a judicial district identified in the 
     notice.
       ``(E) Discretion of applicants.--An applicant or 
     prospective applicant for a comparable biological product 
     under this subsection may not be compelled, by court order or 
     otherwise, to initiate the procedures set forth in this 
     paragraph. Nothing in this paragraph requires an applicant or 
     a prospective applicant to invoke the procedures set forth in 
     this paragraph.
       ``(18) Petitions and civil actions regarding approval of 
     certain applications.--
       ``(A) In general.--With respect to a pending application 
     submitted under paragraph (1) or (2), if a petition is 
     submitted to the Secretary that seeks to have the Secretary 
     take, or refrain from taking, any form of action relating to 
     the approval of the application, including a delay in the 
     effective date of the application, the following applies, 
     subject to subparagraph (E):
       ``(i)(I) The Secretary may not, on the basis of the 
     petition, delay approval of the application unless the 
     Secretary determines, within 30 days after receiving the 
     petition, that a delay is necessary to protect the public 
     health. Consideration of a petition shall be separate and 
     apart from the review and approval of the application.
       ``(II) With respect to a determination by the Secretary 
     under subclause (I) that a delay is necessary to protect the 
     public health:

       ``(aa) The Secretary shall publish on the Internet site of 
     the Food and Drug Administration a statement providing the 
     reasons underlying the determination.
       ``(bb) Not later than 10 days after making the 
     determination, the Secretary shall provide notice to the 
     sponsor of the application and an opportunity for a meeting 
     with the Commissioner to discuss the determination.

       ``(ii) The Secretary shall take final agency action on the 
     petition not later than 180 days after the date on which the 
     petition is submitted. The Secretary shall not extend such 
     period, even with the consent of the petitioner, for any 
     reason, including based upon the submission of comments 
     relating to the petition or supplemental information supplied 
     by the petitioner.
       ``(iii) The Secretary may not consider the petition for 
     review unless it is signed and contains the following 
     verification: `I certify that, to my best knowledge and 
     belief: (a) this petition includes all information and views 
     upon which the petition relies; (b) this petition includes 
     representative data and/or information known to the 
     petitioner which are unfavorable to the petition; and (c) I 
     have taken reasonable steps to ensure that any representative 
     data and/or information which are unfavorable to the petition 
     were disclosed to me. I further certify that the information 
     upon which I have based the action requested herein first 
     became known to the party on whose behalf this petition is 
     submitted on or about the following date: _______