[Congressional Record (Bound Edition), Volume 151 (2005), Part 3]
[House]
[Page 3084]
[From the U.S. Government Publishing Office, www.gpo.gov]




               BUSINESS-AS-USUAL WITH FDA NOT GOOD ENOUGH

  The SPEAKER pro tempore. Under a previous order of the House, the 
gentleman from Texas (Mr. Gene Green) is recognized for 5 minutes.
  Mr. GENE GREEN of Texas. Mr. Speaker, I rise today to address the 
problematic FDA approval process. In recent weeks, we have learned that 
the Federal Drug Administration has established an independent board to 
review post-market drug safety issues. We have also learned that the 
FDA committee issued a recommendation to return Vioxx to the market and 
keep Bextra and Celebrex on the market.
  On the surface, it would seem the FDA has taken measures to address 
drug safety issues. However, we know all too well the devil is always 
in the details, and by looking at these details, it is clear that it is 
just business as usual at the FDA.
  Take the committee that issued the recent recommendations on the COX-
2 inhibitors. Ten of the 32 drug advisers had ties to the 
pharmaceutical industry and, in fact, had received consulting fees in 
the past from the drug manufacturers. I wonder how they voted? Nine to 
one to keep the drugs on the market.
  Without the votes of these industry consultants, the committee would 
have recommended withdrawal of Bextra from the market and keep Vioxx 
off the market. We will never know if their votes are the result of an 
actual conflict of interest.
  Yet to stay above the ethical fray, there should not even be an 
appearance of conflict of interest at the FDA. Their job is too 
important. With nearly a third of the panel receiving consulting fees 
from the industry, the appearance of conflict of interest is 
undeniable.
  Unfortunately, the newly-established Drug Safety Oversight Board will 
suffer from similar problems. Despite the claims that the board will be 
independent, all but two members of the board will be FDA employees. 
What is more, the board will include FDA employees from the Office of 
New Drugs, the entity that approved the drugs in the first place. What 
incentive would board members truly have to conclude the decisions made 
by the FDA were mistakes in judgment and should be reversed? Even less 
likely is the chance that the board members from the Office of New 
Drugs would vote to reverse their own decisions or those of their 
closest colleagues when it comes to drug safety.
  Mr. Speaker, the makeup of this board is more incestuous than 
independent, and, unfortunately, this problem pervades the entire FDA 
approval process, not just approval of pharmaceuticals. We have 
experienced it in our own efforts to keep silicone breast implants off 
the market. When the implant manufacturers came before the FDA, 40 
percent of the advisory panel was made up of plastic surgeons.
  Needless to say, each of the plastic surgeons voted to approve 
silicone breast implants. There is a conflict of interest if I ever saw 
one, since plastic surgeons are virtually guaranteed more business if 
the FDA approves again the use of silicone breast implants.
  Despite the panel's recommendation to approve the device, the FDA, 
thank goodness, recognized the need for additional clinical trials, and 
rejected that application. Now, with another advisory panel in the 
works, we face another uphill battle to ensure that decisions are based 
on science alone, rather than tainted by conflicts of interest.
  Like device approval, the FDA approval process for pharmaceuticals no 
longer reflects public's use of these products. Whereas the FDA 
approval process is based on clinical trials with small samples and 
short durations, the drug industry is now geared to treating chronic 
conditions, such as high cholesterol and arthritis, that affect 
millions of Americans for decades at a time.
  In a rush to get these drugs to market, the FDA relies on preliminary 
studies with little insight into long-term risk, telling manufacturers 
they will get conditional approval as long as they conduct post-market 
studies. The problem is, the FDA has no enforcement authority to 
mandate these studies. With the drugs on the market and the profits 
rolling in, the manufacturers have nothing to gain from conducting the 
post-market studies.
  The statistics paint a crystal clear picture. As of September 2003, 
drug manufacturers agreed to perform 1,338 post-market studies. The FDA 
has reported, however, that two-thirds of them have not even begun that 
agreement from September of 2003. All the while, manufacturers can 
either market these products to physicians or directly to the public, 
who equate the FDA stamp of approval with safety.
  Mr. Speaker, we need to give the FDA the tools to hold drug 
manufacturers to their agreement to do the post-market studies. If they 
are fined for non-compliance or barred from direct advertising until 
the studies are completed, maybe the manufacturers would have an 
incentive to get moving on these studies.
  The FDA's regulatory authority needs some teeth. Creating this Drug 
Safety Oversight Board takes us in the opposite direction by simply 
rearranging the deck chairs on a sinking ship. If this is how the FDA 
intends to get back to business, then business as usual is simply not 
good enough.

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