By Matt Farrell
Maurice D. Hinchey is a Democratic congressman who represents New York’s 22nd District, which includes Tomkins County and seven others. Hinchey is currently serving his eighth term in the House of Representatives and is the author of a “sweeping, but common-sense” bill aimed at reforming the Food and Drug Administration. The following is a statement from the office of Congressman Hinchey in response to Buzzsaw’s questions about the FDA Improvement Act.
Buzzsaw Haircut: What experiences motivated you to investigate the FDA’s relationship with the pharmaceutical industry and ultimately to author the FDAIA?
Maurice Hinchey: The FDA was created in 1906 and evolved over the 20th century to carry out two related but distinct goals on behalf of the American people: to approve new products such as drugs, biologics and devices, and then to oversee the safe use of those products within the marketplace.
As it begins its second century as the nation’s (supposedly) pre-eminent consumer protection agency, the FDA faces crises of confidence both from the public it is supposed to safeguard and from the employees who are meant to carry out its drug approval and safety oversight activities.
I was first drawn to the various problems at the FDA when I started to learn about the actions being taken by former FDA Chief Counsel Daniel Troy. During his time at the agency, Mr. Troy wasted taxpayer money on ideological pursuits that undermined the FDA’s basic missions.
For the first time in history, the FDA’s chief sounsel actively sought out private industrial company lawyers to bring him cases in which the FDA could intervene in support of drug and medical device manufacturers. The cases he pursued were private state civil litigation cases. These are cases in which the court did not asked for FDA’s opinion, involving drug companies and medical device manufacturers who were being sued by people harmed by their products.
During his time at the FDA, Mr. Troy set a new and terrible precedent that is still being pursued, albeit not as actively, by the agency. It should be noted that Mr. Troy has since returned to working directly on behalf of the pharmaceutical industry.
Combined with my work on the House Appropriations Subcommittee on Agriculture, which controls the FDA’s budget, that’s how I started to become aware of the many problems with the FDA.
BH: What negative effects do you believe that relationship has on average consumers?
MH: Put simply, the FDA is broken and must be overhauled. The pharmaceutical industry has supplanted the American people as the FDA’s primary client and number one concern. This development can be attributed to both regulatory problems and leadership problems at the agency.
The FDA is supposed to be in the business of protecting the American people from dangerous drugs, and it is failing miserably at that for a variety of reasons that have led to the agency being closely aligned with the drug industry.
This results in unsafe drugs making their way to drugstores as well as drugs that don’t have adequate warnings about potential serious side effects.
BH: What would the passage of the FDAIA do to regulate what you see as an inappropriate relationship between the FDA and the pharmaceutical industry?
MH: The passage of the FDAIA would free the FDA of its inappropriately close relationship with the pharmaceutical industry and ensure that the agency is solely in the business of protecting the American people.
The legislation would cut the financial link between the FDA and the drug industry. 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. It also prohibits the FDA from negotiating with drug companies over the agency’s budget and ends previous agreements between the FDA and such companies.
The bill would eliminate conflicts of interest on FDA advisory committees. 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. As a result of pressure I’ve helped put on the agency, the FDA has recently moved towards this goal but is not completely there yet.
The FDAIA would create an Independent Center for Drug Safety and Effectiveness. The center would be within the FDA, but the Secretary of Health and Human Services would appoint its director. Different doctors and scientists than the ones who approve a drug would monitor its safety once it hits the market. It would also be given increased funding and authorities to strengthen the FDA’s post-market regulatory functions. Additionally, the FDAIA would empower the FDA and the new center with the authority to require post-marketing studies of FDA-approved drugs, mandate changes to drug labels, impose civil penalties, require patient and doctor education programs, and release critical information about drug safety and effectiveness.
The FDAIA would allow the public to hold drug companies accountable by reversing the pre-emption policy employed by the FDA since 2001 (under Daniel Troy) and restoring the policy used by the FDA for the last quarter-century. This would ensure that individual state consumer protections and other ways that states hold companies legally liable are not pre-empted by FDA regulations unless there is a clear and direct conflict between an FDA regulation and a state regulation.
Finally, the FDAIA would address rampant off-label drug use by requiring 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.
BH: What is the status of the bill in Congress at this point, and what is your assessment of its future?
MH: The FDAIA has been referred to the House Energy & Commerce’s Subcommittee on Health. Quite frankly, it is very difficult to move such a massive piece of FDA reform legislation when the pharmaceutical industry is so powerful. However, I am convinced that the majority of my colleagues will realize that it is time to seriously revamp the FDA. Implementing the FDAIA would do just that and ensure that the health and safety of the American people is the FDA’s top priority.
We’ve had some success with the bill by taking sections of it and introducing them as amendments to related bills. In fact, the House has approved the conflicts of interest section on multiple occasions. I will continue to work very hard to gain support for the bill and move it through Congress. Additionally, I will continue to use my seat on the House Appropriations Subcommittee on Agriculture to hold the FDA accountable via the budget process.
Matthew Farrell is a senior TV-R major who wants to show everyone the Eastern Motors commercial on Youtube. Email him at matt.d.farrell[at]gmail.com.