Hamburg: FDA Now Approving More Drugs During First-Round Than Ever Before

Posted 01 March 2012 | By Alexander Gaffney, RAC 

US Food and Drug Administration (FDA) Commissioner Margaret Hamburg appeared before the House Committee on Appropriations 29 February 2012 to argue on behalf of FDA's Fiscal Year 2013 budget request.

Hamburg made a number of notable regulatory assertions in her testimony to the committee. Among them:

  • "FDA now has the highest first action approval rate for new drugs we have ever had."
  • "We lead the world in the number and speed of drug approvals: of the 57 novel drugs approved by both FDA and the EU between 2006 and 2010, 75% were approved first in the United States.  All 23 cancer drugs approved by FDA and the EU were approved first in the United States."
  • "We also have successfully prevented at least 114 drug shortages.  FDA has sent letters to pharmaceutical manufacturers, reminding them of their legal obligations to report certain discontinuances to the Agency, and urging them to voluntarily notify FDA of all potential disruptions of the prescription drug supply, even when not required by law."
  • "[L]ast year I created the new position of Deputy Commissioner for Global Regulatory Operations and Policy, to fully recognize the need to integrate domestic and foreign inspections, streamline procedures, and seek greater harmonization and opportunities for collaboration with our counterparts in other countries."
  • "We have expanded our efforts to leverage both financial and human capital through collaborations with public and private partners.  For example, we recently entered a new collaboration with the European Medicines Agency (EMA) for shared efficiencies in our inspection programs for human and veterinary pharmaceutical products.   Our Center for Drug Evaluation and Research is working in partnership with the Critical Path Institute, an independent, publicly funded institute, to establish public-private consortia to address key questions in regulatory science."
  • "Nearly 40% of the drugs Americans take are made overseas, and about 80% of active pharmaceutical ingredients are imported.  Approximately half of medical devices used in the United States come from abroad."
  • "In this budget, you will see our commitment to smart regulation and efficacy in medical product review.  We propose investment in improved standardization of electronic submissions for drugs, and modernization of FDA's food-related data bases and data sharing systems.  Proposals for smarter engagement with Chinese regulators will allow FDA to make better evidence-based decisions and allocate FDA resources based on risk.  We propose a new focus on potential uses of meta-analysis for drugs, and streamlined review goals for medical devices."

Hamburg's full testimony, including a section-by-section breakdown of FDA's budget request and an explanation of the medical device and pharmaceutical user fees, can be found on the agency's website.

Read more:

Hamburg - President's Fiscal Year 2013 Budget Request for the FDA

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles