Doctors Call for More Transparency at the FDA
Interview with Joshua M. Sharfstein, MD
As the new administration proposes cuts to health care research spending, a group of doctors are calling on the US Food and Drug Administration (FDA) to become more transparent about its regulatory processes, releasing a document highlighting 18 recommendations for the FDA to increase its transparency.1
If adopted, the new recommendations would be a step towards making more FDA information available to the public, including why certain drugs are approved or denied by the agency. Having this kind of data available would be of great benefit to the scientific community, according to Joshua M. Sharfstein, MD, who is an associate dean of public health practice and training at Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland.
“People often think of the FDA as a regulatory agency, but it’s also a scientific agency, and there’s a lot of really interesting data and analysis that could really be helpful to patients, doctors, and researchers,” Dr. Sharfstein told Practical Pain Management.
The report highlights 5 topics, calling on the FDA to:
- Provide more information on key milestones in the drug approval process
- Disclose more information about its own analysis and decision-making
- Release more information about the application and review process for generic drugs and biosimilars
- Correct misleading information in the market
- Disclose data from scientific studies to enhance the public’s understanding of medical products
In recent years, there has been concerted effort towards increasing transparency at the FDA. In 2010, the FDA established its own Transparency Task Force2 that submitted a number of proposed changes to increase transparency at the agency.
Some of the 2010 proposals were adopted, such as disclosing the names and addresses of entities inspected by the agency, as well as supporting efforts to communicate information, such as the danger of tramadol in children, to the public regarding products.3
The new blueprint document goes further, for instance calling on the FDA to include the class and mechanism of action of any drug disclosed in investigational notices, as well as releasing text to the public regarding Special Protocol Assessment of a drug. Also, if the FDA issues or releases a clinical hold on a product regarding its safety or efficacy, the agency should release a summary of its decisions within 10 days, according to the new recommendations.1
“I think it’s a great thing for the FDA to be more transparent and help people learn from the overall drug development process,” said Dr. Sharfstein, who helped co-author the recommendations. For the physicians prescribing drugs, particularly for pain management, having more transparency could help doctors better understand products being developed, “as well as the opportunities and challenges of future drug and device development,” Dr. Sharfstein noted.
For instance, in 2011 Endo Pharmaceuticals submitted a reformulated version of Opana ER (oxymorphone hydrochloride) featuring abuse-deterrent technology. However, following reports of HIV, hepatitis C, and vascular issues involving intravenous use of the drug,4 a joint FDA advisory committee recently voted 18-to-8 against the drug, citing objections to the drug’s intravenous abuse potential.5
While an argument may be made that the FDA’s regulatory information may affect the pharmaceutical marketplace, Dr. Sharfstein stressed that any information released by the FDA should not be related to the proprietary methods of manufacturing a drug.
“We’re not saying any trade secrets should be released,” said Dr. Sharfstein, who noted that having more efficacy and safety data publicly available actually would be of benefit to the drug development industry.
“If a drug isn’t approved because it caused serious kidney damage, people should know that, so that the next time a drug is being developed, they pay attention to that,” Dr. Sharfstein explained. Indeed, he noted that he already has received support from people working in the pharmaceutical industry about increasing transparency at the FDA.
“It’s stifling for drug development, but it’s also stifling for patients,” Dr. Sharfstein added. Patients oftentimes hear about a promising new drug being put into development but then never find out what happened to it.
“I think [the argument] could be made that people want to know the facts. They want be able to judge for themselves certain things. They want to see the data that decisions are based on. They don’t want to necessarily just take the FDA at its word. More analysis by the FDA could help people understand the FDA better,” said Dr. Sharfstein.
The FDA Blueprint for Transparency document was drafted by a panel of professionals based out of the Johns Hopkins School of Public Health, the Yale School of Medicine, Yale Law School, the Brigham and Women’s Hospital, and Harvard Medical School. This report was made possible by a grant from The Laura and John Arnold Foundation. The authors declared no conflicts of interest.