[Congressional Record Volume 147, Number 12 (Tuesday, January 30, 2001)]
[Senate]
[Pages S774-S777]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Ms. STABENOW:
  S. 215. A bill to amend the Federal Food, Drug, and Cosmetic Act to 
permit importation in personal baggage and by mail of certain covered 
products for personal use from certain foreign countries and to correct 
impediments in implementation of the Medicine Equity and Drug Safety 
Act of 2000; to the

[[Page S775]]

Committee on Health, Education, Labor, and Pensions.
  Ms. STABENOW. Mr. President, today I rise to introduce my first bill 
in the Senate, the Medication Equity and Drug Savings Act, or the MEDS 
Act.
  On January 22, a little over a week ago, I had the privilege of 
addressing my colleagues in my first speech on the Senate floor. The 
topic of the speech was health care, specifically the need to pass a 
strong Patients' Bill of Rights. I pledged my commitment to making 
health care a priority during my tenure in this esteemed body.
  Today, I am pleased to share with my colleagues that I am taking the 
next step in keeping my promise by introducing a bill that addresses 
another priority health care issue: the price of prescription drugs. We 
all know that providing prescription drugs for seniors has become a 
very important issue for the American public. In fact, this was a key 
issue in many campaigns throughout the country, including my own.
  On a fundamental level, I believe everyone should have access to 
affordable prescription drugs, especially senior citizens enrolled in 
Medicare and the disabled. It is an outrage that not only must those 
seniors, who rely solely on Medicare for their health insurance, pay 
for all of their medications out of their own pockets, but that in many 
instances they pay more for the same drug than their counterparts with 
other insurance.
  So we have situations where those without insurance, and most often 
this falls on our seniors--but anyone without insurance is most often 
walking into the pharmacy and paying more. We did a study in my State 
that showed, on average, they paid twice as much as someone with 
insurance for the very same medications.
  I have conducted several prescription drug price studies in Michigan, 
and I have learned that, in fact, there is a genuine problem that 
touches the lives of so many people whom I represent. My concerns have 
been confirmed by literally thousands of letters and e-mails and phone 
calls from seniors and families who cannot afford to buy their 
medications.
  I have been saddened by the sheer number of seniors who confided in 
me that the cost of their drugs is so high that they are often forced 
to give up their meals or are not able to heat their homes. In Michigan 
that can be very serious in the wintertime. This is in order to buy 
their medications.
  These are not new stories. I know my colleagues have heard these 
stories as well, but they are real. They are not just stories. They are 
affecting people today. As we speak, there are seniors somewhere 
deciding whether or not they are going to skip their meals to get their 
medicine, or whether they are going to eat and not have the medications 
they need.
  I also know from hearing from doctors in my district who are worried 
about seniors, who decided to do their own self-regulation. They cannot 
afford all their pills, so they will skip a couple of pills, or they 
will take them every other day, or cut them in half. Oftentimes they 
have been placed in serious jeopardy as to their health because they 
have not been able to afford their medications and they have taken them 
inappropriately.
  The bottom line is that Medicare should include a defined, voluntary 
prescription drug benefit to help cover the costs of prescription drugs 
for seniors and the disabled. I am committed to working with my 
colleagues across the aisle, and the administration, to finish what we 
started last year and create this new component of Medicare that is 
absolutely critical. Without it, we are not fulfilling the promise of 
universal health care for those over the age of 65, or the disabled. If 
we do not cover medications, we are not providing health care in the 
truest sense for those individuals.
  In fact, one of the very first bills I cosponsored this year was S. 
10, a bill that would create this important benefit in the Medicare 
program. I am ready to work with my colleagues to make sure that we do 
whatever it takes to update Medicare and create a defined benefit that 
will make such an incredible difference in the lives of seniors and 
their families in my great State of Michigan and all across the 
country. As we work on this complex issue, there are other approaches 
we can take in a more immediate sense to cut the costs of prescription 
drugs.
  Last year, Congress passed and the President signed into law an 
important new Act that would permit U.S. manufactured, FDA approved 
drugs to be reimported back into the United States by wholesalers. I 
firmly believe that implementing this Act could substantially reduce 
the cost of drugs, not just for seniors, but for everyone.
  Many of my colleagues may remember that during my campaign I 
organized several bus trips to Canada. As you know, Canada is just a 
short trip over a bridge or through a tunnel for many residents of 
Michigan. What I discovered on my bus trips was almost unbelievable.
  With just a short drive across the border, U.S. citizens can 
substantially reduce the cost of their medications by purchasing them 
in Canadian pharmacies. The difference in price for medications was 
absolutely shocking. A price study I conducted, comparing the price of 
several drugs purchased in the U.S. to the Canadian prices, conformed 
what we saw happening on our bus trips--the price of the same drug 
purchased in Canada is substantially lower than the average U.S. price.
  I have brought a chart to the floor to show my colleagues some of the 
incredible differences between the average price in Canada and the 
average price in Michigan. I would like to point those out today.
  Zocor, a drug to reduce cholesterol, costs $109.73 in Michigan for 
50, 5 milligram tablets. The same drug costs only $46.17 in Canada. 
That is a 138 percent difference in price.
  Prilosec, a drug to treat ulcers $115.37 in Michigan for 20, 20 
milligram capsules. The same drug costs only $55.10 in Canada. That is 
a 109 percent difference in price.
  Procardia XL, a drug to treat heart problems, costs $133.36 for 100, 
30 milligram tablets in Michigan. The same drug costs only $74.25 in 
Canada. That is an 80 percent difference in price.
  Norvasc, a drug to treat high blood pressure, costs $116.79 for 90, 5 
milligram tablets. The same drug costs only $89.91 in Canada. That is a 
30 percent difference in price.
  Tamoxifen, a drug to treat breast cancer, costs $136.50 in Michigan 
for a one month supply. The same drug costs only $15.92 in Canada. That 
is an 88 percent savings in price.
  Zoloft, a drug to treat depression, costs $220.64 for 100, 50 
milligram tablets in Michigan. The same drug costs $129.05 in Canada. 
That is a 30 percent difference in price.
  These are all drugs that have been manufactured in the United States 
and have met all FDA manufacturing, safety and purity requirements. 
Furthermore, because these are U.S. drugs, the companies developing and 
manufacturing them have all benefited from substantial assistance from 
the U.S. government, including NIH supported research and the Research 
and Development tax credit. Furthermore, a great deal of this research 
is conducted in state universities.
  I believe that U.S. citizens should have access to these U.S. drugs 
that are sold at lower prices in other countries. Competition is key to 
ensuring prices that consumers are willing to pay. Keeping the Canadian 
border, as well as other borders, closed is an obstacle to competition 
and is serving to maintain artificially high prices for drugs in the 
United States. I believe that permitting U.S. wholesalers, such as 
pharmacies, to bring lower priced drugs back into this country could 
reduce the price of drugs for every American.
  As my colleagues know, the Secretary of Health and Human Services was 
given broad discretion in implementing the wholesale reimportation 
provision of the Act. The former Secretary expressed concerns that the 
provision may not provide cost savings and could pose risks to the 
public health and opted not to promulgate rules. I understand that my 
colleagues are urging the new Secretary to reconsider this decision and 
to begin the implementation process. I am hopeful this may happen and 
would like to work with my colleagues to forward this effort.
  Nonetheless, I recognize that there are some concerns with the law 
enacted last year. My bill addresses these concerns by correcting these 
impediments that may delay the Secretary from promulgating regulations 
and

[[Page S776]]

permitting reimportation. Furthermore, my bill directs the Secretary to 
dispense with the delay and instructs him to begin the rulemaking 
process within 30 days of enactment of the bill.
  The first of the concerns about wholesale reimportation addressed by 
my bill is the sunset provision. My bill would lift the 5 year sunset 
imposed in the Act. Critics argued that sunsetting the provision would 
be a disincentive for distributors to develop ways to comply with the 
reimportation requirements when there was the possibility that 
reimportation could be prohibited again in the near future.
  Careful thought was put into the requirements to ensure consumers 
would be protected. I believe reimporters should be given every 
opportunity to meet these requirement and that removing the sunset will 
give these distributors what they need.
  Further, I believe consumers should always have access to U.S. 
manufactured drugs as long as they comply with FDA safety requirements 
and there is no need for a sunset. If Congress or the administration 
identifies safety concerns in the future, they should be addressed by 
revising the reimportation safety requirements, not sunsetting the 
entire provision of the law.
  The act also did not specify that reimorters could use the 
manufacturers' FDA-approved labels. These labels are required by law if 
the products are to be sold in the United States. My bill would make 
those labels available to the reimporters from the manufacturers for a 
small fee.
  Finally, while the act prohibited manufacturers from entering into 
agreements with distributors that would interfere with reimportation of 
drugs, critics argue this provision was not strong enough to work. My 
legislation tightens up this section by prohibiting manufacturers from 
discriminating against wholesalers simply because they intend to 
reimport the product.
  The bill also has stronger language prohibiting price fixing. 
Wholesale reimportation of prescription drugs is only half the story. 
While I think it is critical that wholesalers be permitted to bring 
U.S.-manufactured drugs back into the country to reduce the price for 
consumers, I also believe individuals should be able to cross the 
border and purchase medication for themselves.
  The act we passed last year did not change the current law which 
prohibits individuals from bringing medications across the border for 
their own use. That is why my bill also makes personal reimportation 
legal. I believe individuals should be able to cross the border and 
purchase prescription drugs at a lower price for their own use.
  The FDA currently has an enforcement policy that permits individuals 
who meet specific requirements to bring a 90-day supply of medication 
with them into the United States from another country, and my 
legislation would codify the current enforcement policy into law. It 
requires essentially the same safety precautions currently expected of 
individuals who bring medication over the border under the FDA's 
enforcement policy.
  The bill also recognizes that some individuals may be too ill to 
cross the borders themselves and permits them to designate a proxy to 
bring the medication back for them as long as they provide a letter 
from their doctor indicating that the trip to another country would 
endanger their health.
  The bill also provides opportunities for individuals to order 
medication over the Internet--there are other new sites being 
developed--and other means--hotlines, et cetera--in order to also have 
prescription drugs delivered by mail.
  I am committed to this issue of making prescription drugs more 
affordable for everyone. This is a matter of fairness. This bill is a 
matter of fairness to Americans, young and old, who need to have access 
to affordable prescription drugs. We as Americans ought not to be 
underwriting the research and at the same time, after the medications, 
as great as they are, are developed, manufactured, and sold, have 
Americans paying on average twice as much as those in other countries. 
That makes no sense to me.
  I am committed to working with my colleagues on both sides of the 
aisle. I appreciate the time I have been given today. This is a 
critical issue. I cannot think of a more serious issue affecting 
particularly older people today than the issue of access to 
medications. I think it is shameful that we have even one senior who is 
having to choose today, tomorrow, or next week between eating or taking 
their medicine. We can fix that. One way is to start with this 
legislation which opens our borders and allows real competition for the 
best price for American citizens.
  I ask unanimous consent that the text of the bill be printed in the 
Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                 S. 215

       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 maybe cited as the ``Medication Equity and Drug 
     Savings Act''.

     SEC. 2. IMPORTATION OF COVERED PRODUCTS FOR PERSONAL USE.

       (a) In General.--Chapter VIII of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 381 et seq.) is amended by adding 
     at the end the following:

     ``SEC. 805. IMPORTATION OF COVERED PRODUCTS FOR PERSONAL USE.

       ``(a) Definitions.--In this section:
       ``(1) Covered product.--The term `covered product' means a 
     prescription drug described in section 503(b)(1).
       ``(2) Foreign country.--The term `foreign country' means--
       ``(A) Australia, Canada, Israel, Japan, New Zealand, 
     Switzerland, and South Africa; and
       ``(B) any other country, union, or economic area that the 
     Secretary designates for the purposes of this section, 
     subject to such limitations as the Secretary determines to be 
     appropriate to protect the public health.
       ``(3) Market value.--The term `market value' means--
       ``(A) the price paid for a covered product in foreign 
     country; or
       ``(B) in the case of a gift, the price at which the covered 
     product is being sold in the foreign country from which the 
     covered product is imported.
       ``(b) Importation in Person.--
       ``(1) Regulations.--Notwithstanding subsections (d) and (t) 
     of section 301 and section 801(a), the Secretary shall 
     promulgate regulations permitting individuals to import into 
     the United States from a foreign country, in personal 
     baggage, a covered product that meets--
       ``(A) the conditions specified in paragraph (2); and
       ``(B) such additional criteria as the Secretary specifies 
     to ensure the safety of patients in the United States.
       ``(2) Conditions.--A covered product may be imported under 
     the regulations if--
       ``(A) the intended use of the covered product is 
     appropriately identified;
       ``(B) the covered product is not considered to represent a 
     significant health risk (as determined by the Secretary 
     without any consideration given to the cost or availability 
     of such a product in the United States); and
       ``(C) the individual seeking to import the covered 
     product--
       ``(i) states in writing that the covered product is for the 
     personal use of the individual;
       ``(ii) seeks to import a quantity of the covered product 
     appropriate for personal use, such as a 90-day supply;
       ``(iii) provides the name and address of a health 
     professional licensed to prescribe drugs in the United States 
     that is responsible for treatment with the covered product or 
     provides evidence that the covered product is for the 
     continuation of a treatment begun in a foreign country;
       ``(iv) provides a detailed description of the covered 
     product being imported, including the name, quantity, and 
     market value of the covered product;
       ``(v) provides the time when and the place where the 
     covered product is purchased;
       ``(vi) provides the port of entry through which the covered 
     product is imported;
       ``(vii) provides the name, address, and telephone number of 
     the individual who is importing the covered product; and
       ``(viii) provides any other information that the Secretary 
     determines to be necessary, including such information as the 
     Secretary determines to be appropriate to identify the 
     facility in which the covered product was manufactured.
       ``(3) Importation by an individual other than the 
     patient.--The regulations shall permit an individual who 
     seeks to import a covered product under this subsection to 
     designate another individual to effectuate the importation if 
     the individual submits to the Secretary a certification by a 
     health professional licensed to prescribe drugs in the United 
     States that travelling to a foreign country to effectuate the 
     importation would pose a significant risk to the health of 
     the individual.
       ``(4) Consultation.--In promulgating regulations under 
     paragraph (1), the Secretary shall consult with the United 
     States Trade Representative and the Commissioner of Customs.
       ``(c) Importation by Mail.--
       ``(1) Regulations.--Notwithstanding subsections (d) and (t) 
     of section 301 and section 801(a), the Secretary shall 
     promulgate regulations permitting individuals to import into 
     the United States by mail a covered product

[[Page S777]]

     that meets such criteria as the Secretary specifies to ensure 
     the safety of patients in the United States.
       ``(2) Criteria.--In promulgating regulations under 
     paragraph (1), the Secretary shall impose the conditions 
     specified in subsection (b)(2) to the maximum extent 
     practicable.
       ``(3) Consultation.--In promulgating regulations under 
     paragraph (1), the Secretary shall consult with the United 
     States Trade Representative and the Commissioner of Customs.
       ``(d) Records.--Any information documenting the importation 
     of a covered product under subsections (b) and (c) shall be 
     gathered and maintained by the Secretary for such period as 
     the Secretary determines to be appropriate.
       ``(e) Study and Report.--
       ``(1) Study.--The Secretary shall conduct a study on the 
     imports permitted under this section, taking into 
     consideration the information received under subsections (b) 
     and (c).
       ``(2) Evaluations.--In conducting the study, the Secretary 
     shall evaluate--
       ``(A) the safety and purity of the covered products 
     imported; and
       ``(B) patent, trade, and other issues that may have an 
     effect on the safety or availability of the covered products.
       ``(3) Report.--Not later than 5 years after the date of 
     enactment of this section, the Secretary shall submit to 
     Congress a report describing the results of the study.
       ``(f) No Effect on Other Authority.--Nothing in this 
     section limits the statutory, regulatory, or enforcement 
     authority of the Secretary relating to importation of covered 
     products, other than the importation described in subsections 
     (b) and (c).
       ``(g) Limitation.--Information collected under this section 
     shall be subject to section 522a of title 5, United States 
     Code.''.
       (b) Conforming Amendment.--Section 801(d)(1) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 381(d)(1)) is amended 
     by striking ``section 804'' and inserting ``sections 804 and 
     805''.

     SEC. 3. CORRECTION OF IMPEDIMENTS IN IMPLEMENTATION OF 
                   MEDICINE EQUITY AND DRUG SAFETY ACT OF 2000.

       (a) Access to Labeling to Permit Importation.--Section 804 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384) 
     is amended--
       (1) in subsection (b)--
       (A) in paragraph (2), by striking ``and'' at the end;
       (B) in paragraph (3), by striking the period at the end and 
     inserting ``; and''; and
       (C) by adding at the end the following paragraph:
       ``(4) specify a fair and reasonable fee that a manufacturer 
     may charge an importer for printing and shipping labels for a 
     covered product for use by the importer.'';
       (2) in subsection (e)(2), by inserting after ``used only 
     for purposes of testing'' the following: ``or the labeling of 
     covered products''; and
       (3) in subsection (h)--
       (A) by striking ``No manufacturer'' and inserting the 
     following:
       ``(1) In general.--No manufacturer''; and
       (B) by adding at the end the following:
       ``(2) No conditions for labeling.--No manufacturer of a 
     covered product may impose any condition for the privilege of 
     an importer in using labeling for a covered product, except a 
     requirement that the importer pay a fee for such use 
     established by regulation under subsection (b)(4).''.
       (b) Prohibition of Pricing Conditions.--Paragraph (1) of 
     section 804(h) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 384(h)) (as designated by subsection (a)(3)(A)) is 
     amended by inserting before the period at the end the 
     following: ``that--
       ``(A) imposes a condition regarding the price at which an 
     importer may resell a covered product; or
       ``(B) discriminates against a person on the basis of--
       ``(i) importation by the person of a covered product 
     imported under subsection (a); or
       ``(ii) sale or distribution by the person of such covered 
     products''.
       (c) Conditions for Taking Effect.--Section 804 of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384) is 
     amended by striking subsection (l) and inserting the 
     following:
        ``(l) Conditions for Taking Effect.--
       ``(1) In general.--Except as provided in paragraph (2), 
     this section shall become effective only if the Secretary 
     certifies to Congress that there is no reasonable likelihood 
     that the implementation of this section would pose any 
     appreciable additional risk to the public health or safety.
       ``(2) Regulations.--Notwithstanding the failure of the 
     Secretary to make a certification under paragraph (1), the 
     Secretary, not later than 30 days after the date of enactment 
     of this paragraph, shall commence a rulemaking for the 
     purpose of formulating regulations to enable the Secretary to 
     implement this section immediately upon making such a 
     certification.''.
       (d) Repeal of Sunset Provision.--Section 804 of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 384) is amended by 
     striking subsection (m).
       (e) Authorization of Appropriations.--Section 804 of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384) (as 
     amended by subsection (d)) is amended by adding at the end 
     the following:
       ``(m) Authorization of Appropriations.--There are 
     authorized to be appropriated for fiscal year 2002 and each 
     subsequent fiscal year such sums as are necessary to carry 
     out this section.''.
                                 ______