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Contact Congressman Hinchey
Congressman Maurice Hinchey, Proudly Representing the 22nd District of New York
Issues and Legislation
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Improving the Food and Drug Administration (FDA)

It has become clear that the Food and Drug Administration (FDA) is too closely tied to the industries it regulates and is unable to protect the public from unsafe drugs. Vioxx, Celebrex, and antidepressants are just three recent examples of how the FDA failed to quickly respond to numerous warning signals and put millions of Americans at risk. These failures demand congressional action. I have authored the FDA Improvement Act (FDAIA) of 2005 in order to reshape the FDA, improve drug safety and make sure that the only client the FDA serves is the American public.

Read more about Congressman Hinchey’s efforts to end the FDA’s inappropriately close ties to the drug industry.

Details of the the FDA Improvement Act follow below:


FDA Improvement Act of 2005 (H.R. 2090)

Bill Summary

The FDA Improvement Act of 2005 (FDAIA) is a sweeping, but common sense, piece of legislation that will cut the inappropriately close ties between the FDA and the drug industry and vastly improve the FDA's drug safety operations.

Ends The Cozy Relationship/Cut Financial Link Between FDA & Drug Industry

The Problem:

In 2001, fees paid by drug companies funded 32 percent of the FDA's budget for drugs. Today, that figure is nearly 50 percent and it is expected to grow higher. Making matters worse, the FDA must negotiate with the drug industry on how those user fees are allocated. This financial dependency, along with the FDA's constant negotiations with companies over how to spend their fees, is the foundation for the "cozy relationship" that exists today between FDA and the pharmaceutical industry. The FDA now depends on the drug industry for its financial survival and, as a result, it has become less and less accountable to the general public and more and more beholden to the drug industry.

This is unacceptable and unsustainable. The FDA's mission is to protect the public health, but it cannot possibly do so if it is forced to rely on drug industry funds and approval for its basic operations.

The Solution:

  • The FDAIA prohibits the FDA from collecting fees paid by companies.
  • Instead, the bill redirects those fees to the general fund of the U.S. Treasury.
  • The bill creates mandatory funding levels to cover the cost of the functions previously paid directly by drug companies.
  • This legislation also prohibits the FDA from negotiating with drug companies over where and how to spend its resources and it terminates all previous agreements reached between FDA and such companies.

These common sense provisions will create a firewall between the FDA and the industry it regulates, reversing the "cozy relationship" between the two that exists today. Since the inception of user fees in the early 1990's, the FDA has treated drug industry as a "client," instead of a regulated entity. The FDAIA will free the FDA from the industry's grip and ensure that the only "client" served by the FDA is the American people.

Eliminates Conflicts-of-Interest On FDA Advisory Committees

The Problem:

The FDA relies on outside advisory panels to provide recommendations on the safety and effectiveness of drugs and medical devices. However, many of the scientists who serve on these panels have financial conflicts-of-interest that bias their recommendations, or at least give the perception of bias. For example, 10 of 32 scientists on the FDA's Cox-2 advisory panel had ties to manufacturers of the drugs. Had their votes had been eliminated, two of the three drugs in that class would have been voted down by the panel, instead of receiving narrow support. In April, an FDA panel reviewing the evidence supporting the controversial silicone gel breast implants included a scientist that had made a promotional CD supporting the products.

These advisory panels are critical components of FDA's regulatory scheme and should be composed of scientists who do not have any financial ties to the manufacturers of the products under the panel's review. Without this guarantee, there is no way for the public to be assured that the advisory panel's recommendations are fair and unbiased.

The Solution:

  • The FDAIA would require that all FDA advisory panels be composed of qualified experts who do not have any financial ties to companies who have a stake in the topic under discussion.
  • Requires the FDA to post on its website the membership of all advisory board committees at least 30 days prior to the panel's meeting and provides the public with no less than 20 days to comment on the committee's makeup.

Improves Drug Safety

The Problem:

It has become apparent that the FDA is unable to adequately protect the public from unsafe drugs. Vioxx, Celebrex, and SSRI's are just three examples of how the FDA failed to quickly respond to numerous warning signals, putting millions of Americans at-risk. The ability of drug companies to mass market their products and bypass the advice of doctors has resulted in tens of millions of people telling their doctors what drugs they want to take, not the other way around. Unfortunately, the FDA is unable to meet the enormous demands created by this new dynamic.

Additionally, the current system of having the same doctors and scientists who approve a drug be the ones who monitor its safety once it hits the market is ineffective since many of them would not want to admit a previous error by pulling a drug they had originally deemed safe.

The Solution:

  • The FDAIA creates an independent Center for Post-Market Drug Safety & Effectiveness responsible for regulating all approved drugs, as well as all advertisements and promotions associated with those products.
  • The Center will be within the FDA, but the Secretary of Health and Human Services will appoint its director.
  • Different doctors and scientists than the ones who approve a drug will monitor its safety once it hits the market.
  • It will also be given increased funding and authorities to strengthen the FDA's post-market regulatory functions and abilities.

Empowers The FDA To Mandate Changes Over Drug Industry

The Problem:

The FDA currently does not have the legal authority to adequately regulate drug safety. It cannot mandate post-marketing studies, label changes, or impose civil penalties. As a result, the FDA is hamstrung in its ability to effectively protect the American people from unsafe drugs.

The Solution:

  • The FDAIA empowers the FDA and the new Center with the legal authority to require companies to conduct post-marketing studies of FDA-approved drugs.
  • The measure provides the FDA and the new Center with the legal authority to mandate changes to FDA-approved drug labels.
  • Includes additional provisions to help mitigate drug safety risks.
  • Allows the FDA to impose civil penalties of $50,000 per day in violation up to $50 million for violating FDA drug regulations. Currently, the FDA can only impose civil penalties on medical device companies, not drug companies.

Allows Public To Hold Drug Companies Accountable

The Problem:

Under a policy instituted by former FDA Chief Counsel Daniel Troy, the FDA argued that the public should be prohibited from filing lawsuits against makers of FDA-approved products. Troy worked to protect companies from being held liable for any harmful effects caused by products such as Vioxx. That policy is still in effect today.

The Solution:

  • The FDAIA reverses the preemption policy employed by the FDA since 2001 and restores the policy used by the FDA for the last quarter-century, which ensured that individual state consumer protections and other ways in which states hold companies legally liable, are not preempted by FDA regulations unless there is a clear and direct conflict between an FDA regulation and a state regulation.

Addresses Rampant Off-Label Drug Use

The Problem:

Off-label drug use is the practice of prescribing a drug for a use not approved by the FDA. It is illegal for a drug company to advertise a drug for off-label use, but it is legal for a doctor to prescribe a drug for off-label use. There is no reliable data to quantify the actual extent practice, but by most accounts it is rampant and patients often have no idea they are being prescribed a drug for an unapproved use. While there may be benefits to off-label prescriptions, there is a considerable lack of information about a drug's effects when it is used for unapproved purposes. This lack of information means a patient and his or her doctor do not know all the possible side effects and whether or not there is convincing evidence that the drug is even effective at treating the unapproved indication.

The Solution:

  • FDAIA would require doctors to inform their patients when they are prescribing a drug for an unapproved use. This would ensure, at the very least, that a patient knows when they are being prescribed a drug for a use not approved by the FDA.

Text of the Bill (H.R. 2090)

List of Cosponsors

 

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