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Lawmakers should not interfere with the current off-label prescribing system because doing so would limit patients’ access to the most innovative treatments, a high-ranking FDA official says.
The Senate Health, Education, Labor and Pensions committee will hold a hearing this week on industry user fees, continuing a series of congressional efforts to look into the FDA’s drug review process.
Consumers Union is calling for changes to strengthen S.484, the “Enhancing Drug Safety and Innovation Act,” because the current version will not make a major difference in the FDA’s drug safety processes, the organization said.
Rep. Henry Waxman (D-Calif.), chairman of the House Oversight and Government Reform Committee, last week sent letters to Boston Scientific and Johnson & Johnson (J&J) asking the firms for information on their drug-eluting stents.
Organizations representing more than 60,000 pharmacists sent a letter to three senators discouraging them from introducing a bill that would strengthen federal regulations on compounded drugs.
Sens. Max Baucus (D-Mont.) and Chuck Grassley (R-Iowa) have asked FDA Commissioner Andrew von Eschenbach to respond to an independent review that called the agency’s postmarketing surveillance system “dysfunctional.”
As the debate over how the FDA should approve follow-on biologics continues, lawmakers acknowledged more work is needed to satisfy certain patient safety and interchangeability concerns raised by the pharmaceutical industry.
The authors of the legislation that paved the way for improved market access for generic drug firms are confident that legislation to facilitate biogeneric entry is likely to move forward before the end of 2007.