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Reps. Henry Waxman (D-Calif.) and Edward Markey (D-Mass.) have introduced legislation they say goes further to strengthen the FDA’s drug safety review processes than the bill’s counterpart in the Senate.
Sen. Chuck Grassley (R-Iowa) said comments from FDA Commissioner Andrew von Eschenbach discourage openness within the agency and raise questions about what problems the agency might be trying to conceal.
Language in newly entered free trade agreements covering data exclusivity and patent extension could delay generic drug entry in foreign markets where access to low-cost medicines is highly needed, a bipartisan group of lawmakers contend.
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 draft “Safe Drug Compounding Act of 2007” would stop illegal mass manufacturing of drugs while allowing patients access to legally compounded medications, the Consumer Health Alliance for Safe Medications (CHASM) said.
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.
Sen. Chuck Grassley (R-Iowa) said comments from FDA Commissioner Andrew von Eschenbach discourage openness within the agency and raise questions about what problems the agency might be trying to conceal.
The two lead sponsors of legislation on improving the FDA’s drug safety efforts told the agency that, while they don’t like the idea of industry fees paying for agency reviews, the way these funds are used can be changed to balance the quick approval of drugs with increased safety monitoring throughout a product’s life cycle.
A biogeneric approval mechanism may lead regulators to create separate rules for these types of treatments, according to former U.S. Centers for Medicare & Medicaid Services (CMS) Administrator Mark McClellan, who said he is optimistic that the U.S. Congress will pass legislation this year easing the entry of follow-on biologics.
The two lead sponsors of legislation on improving the FDA’s drug safety efforts told the agency that, while they don’t like the idea of industry fees paying for agency reviews, the way these funds are used can be changed to balance the quick approval of drugs with increased safety monitoring throughout a product’s life cycle.