Petitions to FDA Delay Generic Drugs 7/10/2006 3:09:00 PM
Critics Say Big Pharmaceutical Companies Misusing Process to Squelch Cheaper Generic Drugs Making It To Market.
Congress, finally is taking a hard look at the FDA, who say they are concerned that the FDA may be getting subverted by the brand-name drug industry. Leaders in the generic drug industry, have complained loudly that "citizen petitions" -- requests for agency action that any individual, group or company can file -- are being misused by brand-name drug makers to stave off generic competition.
The simple act of filing a petition triggers another round of time-consuming and often redundant reviews of the generics by the FDA, drugs that have already passed such an inspection and can take months or years. In the process, consumers continue to pay millions of dollars more for the brand-name drugs as the FDA continues in their same corrupt vein.
Statistics collected by the staff of Sen. Debbie Stabenow (D-Mich.), who has introduced legislation with Sen. Trent Lott (R-Miss.) that would rein in industry-filed citizen petitions, show that 20 of the 21 brand-name petitions settled by the FDA since 2003 were ultimately rejected. "The brand-name drug industry has found a major new loophole," Stabenow said in an interview. "The way things stand now, the drug companies can get hundreds of millions of dollars of profits from the delay." In a letter sent a few weeks ago to FDA Acting Commissioner Andrew von Eschenbach, Stabenow and Lott estimated that the delay in approving a generic version of the antidepressant Wellbutrin XL is costing consumers $37 million a month. "Biovail's petition is a sham, designed solely to delay the onset of generic competition for its Wellbutrin XL product," Impax told the FDA in a letter. "Biovail has wasted FDA's and Impax's time and resources and has likely cost the American public millions of dollars in taxes and health care expenditures in selfish pursuit of further undeserved windfall profits."
By regulation, all generic drugs must be "bioequivalent" to the brand-name drugs they copy and must have the same effects and dependability. Industry-sponsored citizen petitions often challenge the process by which bioequivalence was tested. Because generics generally cost 25 percent to 75 percent less than brand-name products, the sums of money at stake can be enormous -- for the brand-name company, the generic maker, patients, insurance companies and government programs. Wellbutrin XL (a once-a-day formula of bupropion hydrochloride with fewer side effects than the original) costs $1 to $5 a pill and earns about $800 million a year for Biovail and GlaxoSmithKline PLC, which developed the drug. An Impax spokesman said his company planned to sell its generic version, if approved by the FDA, for "a considerable discount."
Making changes to the citizen petition process is a high priority for the Generic Pharmaceutical Association. Its president, Kathleen Jaeger, said her group considers “blocking” those same petitions by pharmaceutical houses to be among the greatest obstacles facing the industry. This is not the first time that the generic industry has complained about citizen petitions that it believed were unfairly blocking generic applications. The Clinton administration responded to those complaints in 1999 with a proposal that would have changed the way the FDA received and handled citizen petitions. PhRMA strongly opposed the rule, and the Bush administration withdrew it in 2003. Jaeger said the generic industry was working hard with Congress at that time to close other loopholes in the patent system that allowed makers of brand-name drugs to extend their time for exclusive sales. "We were working so hard to get that legislation passed that we didn't really focus on what was happening with the citizen petition rule," she said, "so some of what we won in Congress, we lost to the citizen petitions."
Stabenow and Lott, who are trying, in their bill, to reduce the petitions, said in their letter to von Eschenbach that "the Senate Appropriations Committee recognized the unintended effect citizen petitions were having on the approval of [generic drug applications] and directed the FDA to provide a written report explaining the process and suggesting improvements. . . . It is our understanding the FDA has not moved forward with this request."
Bribes and kickbacks are the norm at the FDA. Conflict of interest is something taken pride in with fancy rhetoric. Pharmaceutical firms give millions and millions of dollars to Congressional war chests.
