BIO Letter to Congress on Drug Reimportation

Washington, D.C. (September 29, 2000) Carl B. Feldbaum, President of the Biotechnology Industry Organization (BIO) issued the following letter to members of the House and Senate today on the drug reimportation proposal before Congress:

September 29, 2000

Regarding: Senate Amendments to Agriculture Appropriations Committee Bill on Regulation of Imported Prescription Drugs

Dear Member of Congress:

We are writing to urge Congress to reject amendments to the Agriculture Appropriations bill or any other legislation that would undermine the FDA’s patient protection powers and resources regarding imported prescription drugs.

Seniors need better access to prescription drugs, and BIO has long supported efforts to provide them with increased access to these drugs. However, we are concerned that Congress is focused on stop-gap, election-year solutions that will harm the FDA, put the health of seniors at risk and undermine incentives for biomedical research.

Next week BIO intends to release a report entitled Biotechnology’s Impact on Diseases of the Elderly that dramatically demonstrates how the biotechnology industry is indeed the best hope for bringing new, breakthrough drugs to market, drugs that offer the best opportunity to deal with age-related diseases.

The drug-importation amendments in the Agriculture Appropriations bill, designed to permit U.S. patients (House-passed provisions) and pharmacies and wholesalers (Senate-passed provision) to import prescription drugs from Mexico and Canada or any other country, seek to take advantage of the fact that Mexico and Canada and most other countries have government-imposed drug price controls, so the prices for prescription drugs are artificially low. We understand that differentials in price between foreign nations and the United States are an inviting target, but that provides no justification for jeopardizing vital health and safety protection for patients.

The biotechnology industry supports a strong FDA. Our industry pays hundreds of millions of dollars in user fees to support FDA regulatory programs. We support full funding of the FDA so that it can provide professional services to protect patients. This is why we oppose the pending proposals. This is not a vote on prescription drug prices; it’s a vote on FDA regulatory powers to protect patients.

Better prescription drug coverage is the solution to the problem these drug-import proposals seek to address. BIO supports providing increased access to prescription drugs for our nation’s elderly. We believe this critical component of health care should be provided as part of overall Medicare reforms. BIO believes Congress should focus our resources on the sickest and poorest patients and should start with stop-loss coverage for prescription drugs to ensure access.

BIO is working with members of Congress to find solutions to the drug-coverage problem for senior citizens. We urge members not to support ill-advised drug-import measures, as they will compromise the health and safety of American citizens and undermine incentives for research on breakthrough medicines.

Any measure that, in effect, imports the Mexican, Canadian or other government drug price controls undermines incentives for biomedical research to develop the next generation of drugs. For too many seniors’ diseases, there is no medicine at any price, here or abroad, to provide relief. The biotechnology industry is dedicated to bringing breakthrough products to market, but this is an industry that could not exist under policies like those we find abroad. The U.S. biotechnology industry is preeminent internationally because it has been able to thrive in current U.S. market conditions.

Most biotechnology companies have no products for sale in the United States or abroad. They are spending hundreds of millions on research in the hope that they will have products for sale. As biotechnology companies bring new medicines to market, they will soon want to ensure that the products that reach patients are the same as our companies manufacture, meet their high standards for efficacy and potency, and have not been damaged in the chain of distribution. They cannot do so under the terms of some of these pending proposals.

We urge you to oppose any amendment or proposal that would undermine patient protections and incentives for breakthrough biomedical research.


Carl B. Feldbaum
Biotechnology Industry Organization

BIO represents more than 920 biotechnology companies, academic institutions and biotech centers in all 50 states and in 26 other nations. BIO members are involved in the research and development of health-care, agricultural, industrial and environmental biotechnology products.