Rep. Stupak Works To Increase FDA Oversight, Improve Prescription Drug Safety

Main Category: Pharmacy / Pharmacist
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 21 Feb 2008 - 7:00 PDT

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The Wall Street Journal on Wednesday examined House Energy and Commerce Oversight and Investigations Subcommittee Chair Bark Stupak's (D-Mich.) efforts to increase FDA oversight and improve the safety of prescription drugs. According to the Journal, Stupak is "at the center of an aggressive effort by congressional Democrats to spotlight what they say are problems with the Bush administration's position on consumer-safety issues."

The subcommittee is investigating how FDA handled Baxter Healthcare's blood thinner heparin, which has been linked to adverse reactions and four deaths. The "investigation will focus on why the FDA failed to inspect a Chinese plant making some of Baxter's active ingredient, and it is also likely to zoom in on broader concerns about the agency's technology," according to the Journal. The subcommittee also is examining blockbuster drugs -- such as Pfizer's statin Lipitor, Merck and Schering-Plough's cholesterol drug Vytorin, and anemia drugs made by Amgen and Johnson & Johnson -- as well as Sanofi-Aventis' antibiotic Ketek. In addition, Stupak is holding hearings on the safety of food, drugs and medical devices that come into the U.S. from abroad.

Stupak and House Energy and Commerce Committee Chair John Dingell (D-Mich.) say the investigations are building a case for broader changes within FDA, the Journal reports. Both lawmakers support legislation that would charge companies fees to fund inspections of imported food and drugs, but the measure has not moved forward. Stupak, who recently called for the resignation of FDA Commissioner Andrew von Eschenbach, said he also wants to examine other issues, including granting FDA the power to issue subpoenas, granting the agency authority to regulate direct-to-consumer advertising for drugs and increasing agency funding.

Energy and Commerce Committee ranking member Joe Barton (R-Texas) said that although Stupak has "made some mistakes," including calling for von Eschenbach's resignation, he has "a very bulldog approach to things, which in oversight is a good thing." Pharmaceutical Research and Manufacturers of America CEO Billy Tauzin, who is a former Energy and Commerce Committee chair, said Stupak is "doing his job," and FDA "certainly would do a far better job if it were properly funded." He added that the increased scrutiny of FDA might be making the agency more cautious in reviewing new drugs (Wilde Mathews, Wall Street Journal, 2/20).

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