Transcript of Congressman Hinchey's Remarks on House Floor - July 13, 2004

My amendment cuts $500,000 from the office of the Commissioner of the Food and Drug Administration and adds that money to the FDA's Center For Drug Evaluation and Research. It is my intention that the funds should be cut from the FDA's Office of General Counsel, which is housed in the Commissioner's office, and that those funds be added to the FDA's Division of Drug Marketing, Advertising and Communication, which is located in the Center for Drug Evaluation and Research.

The mission of the Food and Drug Administration is to ensure that the public is protected from unsafe food, drugs and medical products. The FDA's Chief Counsel, however, has taken the agency in a radical new direction, and in doing so has wasted taxpayer money on pursuits that are undermining FDA's basic mission.

For the first time in history, FDA's Chief Counsel is actively soliciting private industrial company lawyers to bring him cases in which FDA can intervene in support of drug and medical device manufacturers. The cases he is seeking out are private, State, civil litigation cases. These are cases in which the court has not asked the FDA's opinion. These are cases involving drug companies and medical device manufacturers who are being sued by people who have been harmed by their products. This has never happened before, and according to the FDA, it has spent over 622 hours on these cases.

I have also uncovered what amounts to a pattern of collusion between the FDA and the drug companies and medical device manufacturers whom the FDA is defending in State courts. Here are three such cases:

One of Mr. Troy's clients, Chief Counsel for the FDA, Mr. Troy's clients at Wiley, Rein was Pfizer, which in the 3 years prior to his appointment in the FDA paid that firm $415,000 for services provided directly by Mr. Troy .

In July of 2002, Malcolm Wheeler, an attorney for Pfizer, called Mr. Troy , then FDA's Chief Counsel, and requested that FDA get involved in the private State lawsuit against Pfizer that was ongoing in California. Mr. Troy obliged, and in September, less than 2 months later, FDA through the Department of Justice filed a court brief in support of Pfizer.

That same July, Mr. Troy also had a meeting with Ms. Michele Corash from Morrison and Foerster. Morrison and Foerster, one of the world's largest firms, is based in California. At the time of this meeting, it was representing Glaxo Smith Kline in a private lawsuit in California that revolved around California's Proposition 65, or the Safe Drinking Water and Toxic Enforcement Act. Michelle Corash was the lead attorney in that case. On September 12, less than 2 months after that meeting, Mr. Troy's FDA filed a brief in support of Ms. Corash's client Glaxo Smith Kline.

This pattern continued in 2003. On December 12, 2003, FDA filed a statement of interest in the case of Murphree v. Pacesetter in support of the medical device manufacturer Pacesetter. The company was being sued in Tennessee State court for a faulty pacemaker. My office has obtained the letter to FDA dated November 5, 2003, from the law firm of Feldman, Gale and Weber directing FDA on how it should assist its case against the person whose Pacesetter did not work. The firm was representing the Pacesetter.

Another pursuit of FDA's Chief Counsel was his publishing in the Federal Register a notice questioning whether FDA's own regulations complied with the first amendment. This notice is troubling because it would surely be used against FDA in lawsuits.

Because of the unusual nature of this action, CRS looked for a precedent, and what it found was this: ``We were not able to uncover any similar instance where a Federal agency issued a notice seeking the type of public comment on a constitutional issue and regulatory issue such as this one which was sought out by Mr. Troy .''

After receiving 700 filings and spending 600 hours on this matter, the FDA decided to drop it, once again wasting taxpayer money.

But this amendment is about more than just an FDA office wasting money. FDA's Chief Counsel is taking actions to undermine FDA's ability to carry out its mission. He is shutting down avenues used to expose fraud in the drug industry. He is making it easier for drug companies to produce misleading advertisements.

Instead of spending taxpayer dollars to make it easier to defraud the public, the FDA should be protecting the public and its interests.

My amendment would add funds to FDA's Division of Drug Marketing, Advertising and Communication. This division, which consists now of only seven people, is responsible for reviewing the accuracy of prescription drug consumer-directed advertisements. Last year, these seven people reviewed 38,400 such ads. This is a 6 percent increase over the previous year.

However, despite the increase in ads reviewed, the number of enforcement letters sent by FDA to drug manufacturers for false and misleading advertisements dropped 75 percent. They are only doing 25 percent of the work that they did previously. It dropped 75 percent in 2003.

The reason for this drop was not the drug companies suddenly cleaned up their act. In fact, all public information indicates the contrary. The real reason is a conscious effort on the part of the FDA to weaken advertising regulations.

Shortly after the Bush administration took office, FDA's Chief Counsel instituted a policy that all advertising warning letters go through his office, the Office of Chief Counsel.

Prior to this, all letters were sent from the Division of Drug Marketing. So now that they go through the Office of Chief Counsel, we have had this 75 percent reduction in enforcement. This extra money would strengthen FDA's division for drug marketing's ability to identify misleading ads that it sends to the FDA's Chief Counsel's office. It is clear this division is overwhelmed and requires more assistance. I urge support for this amendment.