GAO asked to investigate FDA disciplinary delays
WASHINGTON The ranking Republican members of the House Energy and Commerce Committee and the Oversight and Investigations Subcommittee have written a letter to the Government Accountability Office stating that the office should investigate delays by the Food and Drug Administration in disciplining researchers who break rules while testing drugs in people.
The representatives, Joe Barton of Texas, who is the top member of the Energy and Commerce Committee, and John Shimkus of Illinois, the top Republican for the Oversight and Investigations Subcommittee, cited a report from Bloomberg in its letter addressed to the GAO. That report said the FDA failed to complete disciplinary action against 12 researchers after proposing that they be disqualified from trials based on findings that they violated agency rules to protect patients and ensure accurate data.
“The FDA has waited months and sometimes years to take action against doctors who lied about their work on critical clinical studies of new drugs and who put their own patients at risk,” Barton said in a statement. “There’s just no excuse for not invoking the authority the FDA already has to rapidly disqualify liars from taking any further role in these drug studies.”
In addition to investigating delays, the lawmakers’ letter asked the GAO to examine whether the FDA’s oversight is “effective in identifying clinical investigators whose practices or conduct may compromise the quality and integrity of clinical data or the safety of participants in clinical trials.”
Pfizer wins Celebrex patent challenge
NEW YORK Pfizer announced that the Court of Appeals for the Federal Circuit has upheld two main patents for the company’s anti-inflammatory drug Celebrex, according to published reports.
Teva had challenged the patents, but the court ruled that the patents are valid and enforceable, but they did rule that a third patent, covering the treatment of inflammation was invalid.
Nevertheless, the decision blocks Teva from launching a generic version until May 2014.
The drug had global sales of $1.7 billion in 2007. Bear Stearns analyst project that it will reach global sales of $2.5 billion in 2008, an increase of 9 percent, and that the drug will pull in $3.1 billion by 2012.
FDA to enhance warnings on Tussionex
WASHINGTON UCB, the maker of Tussionex cough medicine, has reached out to the Food and Drug Administration to place a stronger warning on the drug. This new push stems from the report of five deaths of young children from taking Tussionex.
According to published reports, the deaths were all children under age 6, but the Belgian pharmaceutical company said that the drug is only to be taken for children and adults ages 6 and up.
Tussionex Pennketic Extended- Release Suspension contains the pain reliever hydrocodone. According to reports, the FDA is planning to issue an alert about the effects of Tussionex.