The Boston Globe on ran a story on Senate Finance Committee Chair Chuck Grassley (R-Iowa) and his role as the driving force behind a congressional charge to change FDA. According to the Globe article, Grassley has “exposed internal FDA memos, emails and conversations to unprecedented public scrutiny” in his attempts to “prod the agency to change a culture that stifles and punishes dissenters.” Grassley feels the FDA puts too much emphasis on approving drugs and not enough on follow-up on the safety of already approved drugs. Grassley has proposed legislation that would create an Office of Drug Safety at FDA that would operate separately from drug safety reviewers at the agency’s Office of New Drugs. According to the Globe, many at the FDA oppose the legislation.
Grassley has urged lawmakers to consider legislation that would address FDA’s postmarket regulation of approved drugs. Grassley is pushing his bill (S 930), co-sponsored by Sen. Christopher Dodd (D-Conn.), which would authorize FDA to conduct postmarket drug reviews. Citing a GAO report that said the FDA “lacks a clear and effective process” for tracking safety issues related to approved drugs, GAO researchers concluded that that disputes between FDA’s Office of Drug Safety and Office of New Drugs slowed the evaluation process.
Currently, both the Office of Drug Safety (ODS) and the Office of New Drugs (OND) are part of CDER, an arrangement that some feel results in an improper balance of power between postmarket safety and the reviewing decision. The GAO does not specifically advise taking the drug safety office out of CDER but recommends that the FDA commissioner clarify its role. The GAO reports that the Office of New Drug has sometimes excluded analyses by drug safety staffers at advisory committee meetings held to review particular medications. The GAO also recommended that Congress consider expanding the FDA’s authority to require drugmakers to conduct postmarket safety studies.
One of the FDA problems that have attracted the attention of Senator Grassley include investigations into misconduct during the largest of three key trials to measure the safety of the antibiotic Ketek, made by Sanofi-Aventis. An FDA official called in May for a drug company to halt clinical trials of an antibiotic in children because the drug could be deadly, according to internal memorandums sent to other FDA officials. Ketek is being tested as a treatment for ear infections and tonsillitis in nearly 4,000 infants and children in more than a dozen countries, but Ketek, which is currently approved for use only in adults, has been reported to cause liver failure, blurred vision and loss of consciousness in adults.
An official in the Office of Drug Safety at the FDA wrote that there is growing evidence that Ketek is unusually toxic and that the agency should consider forcing Sanofi-Aventis to withdraw Ketek from the market, severely restrict its uses, even in adults, or add a prominent warning to its label about potentially fatal side effects. The FDA said it dismissed the study’s results and instead asked the company to report its experience with Ketek in Europe, where it was approved in 2001. In April 2004, the FDA approved Ketek to treat sinusitis, bronchitis and pneumonia based on data in Europe.
Since then, problems with the drug have surfaced with reports of 110 cases of liver problems associated with Ketek, most of which occurred in otherwise healthy people, according to the safety review. Sanofi-Aventis has now suspended enrollment in studies of Ketek in children. Sanofi said the Food and Drug Administration did not request the action. It also said the suspension was not linked to a report in the New York Times that said an FDA official last month requested the trials be halted because Ketek could be deadly.
