In her last public speech, the outgoing head of the Food and Drug Administration issued a stern warning to any future efforts to curb agency regulations.
Any legislation that peels away regulations to review safety and efficacy of new drugs “ultimately wouldn’t just damage patients but industry as well,” Margaret Hamburg said at the National Press Club on Friday. Hamburg will leave her post next week after serving for six years.
Hamburg specifically mentioned the 21st Century Cures initiative spearheaded by the House, which aims to speed development of medical products to get them on the market faster.
Final legislation in the House has yet to be introduced, but lawmakers have hinted it will include a section that allows the FDA to approve drugs based on early stage clinical data. The package also would modernize clinical trials and spur research into new treatments.
The agency already has several approval pathways that speed development of drugs that have unmet needs or are better than a therapy already on the market.
But Hamburg said shortchanging requirements for reviewing safety and efficacy would be a bridge too far. She said there was a misperception that you could “speed innovation by lowering standards for safety and efficacy.”
Hamburg was also concerned Congress would shoulder the agency with additional responsibilities but not give it any money to meet them.
The commissioner, who declined to say what she would do next, also said she hopes she would be remembered for rebuilding public confidence in the agency. Hamburg said she worked to increase transparency at the agency and made a new commitment to using regulatory science on which to base regulations.
“To be effective the FDA must do vital work with the trust and confidence of the public,” she said.
When Hamburg took office in 2009, the agency was battered by several food-borne disease outbreaks such as peanut butter tainted with salmonella that sickened more than 700 people.
Hamburg, however, has been criticized for the agency’s response to some public health events. Most notably was an outbreak of fungal meningitis from contaminated pharmaceuticals.
The 2012 outbreak has killed more than 100 people. The drugs came from a New England compounding pharmacy, which can combine two or more drugs to create a treatment for a specific patient.
Agency oversight of compounding pharmacies was murky and Hamburg was criticized for not doing more to clamp down on the New England pharmacy, which the agency had repeatedly inspected. The FDA received new powers over large compounding pharmacies in 2013.
Hamburg also defended her six-year tenure from criticism from public health advocates that the agency was too cozy with the pharmaceutical industry.
“We obviously operate in a framework with clear conflict-of-interest rules,” she said.
She also emphasized the benefits of working with industry on how to regulate products.
“We need to have a full and open exchange of information,” she said. “In many instances there is great value in having industry and academia and government in shaping research and critical areas.”
