May 19, 2010 (CIDRAP News) As part of a push for more government transparency, the US Food and Drug Administration (FDA) today released a draft report detailing 21 steps it could take to share more information, such as providing fuller explanations of its decisions and posting more inspection reports.
Most of the proposals in the 65-page report apply to drugs and devices that the FDA regulates, but some measures address food safety issues such as import evaluations, facility inspections, and product recalls.
The proposals reflect President Barack Obama's goal of creating more openness in government and are part of a transparency initiative launched by Dr Margaret Hamburg when she stepped into her new role as FDA commissioner in June 2009.
In a New England Journal of Medicine report today on the FDA's transparency initiative, two high-ranking agency officials laid out the overall rationale for the proposals. Afia Asamoah, an attorney who directs the FDA's transparency initiative, and Joshua Sharfstein, MD, deputy commissioner and chairman of the FDA's transparency task force, wrote that the FDA already provides ample information about the regulatory process for medical products but, for example, does not routinely post dates and results of facility inspections.
Businesses, along with, would benefit from greater FDA transparency, they wrote. "Regulated companies have expressed interest in additional transparency about the standards to which their products are held, the process for soliciting guidance from the agency, and the progress of regulatory efforts at the agency."
The transparency task force solicited extensive public input when forming the proposals included in today's report, Asamoah and Sharfstein wrote. Over the past year group held two public meetings, participated in several listening sessions, launched a blog, and established a docket to solicit ideas from the public.
At a press conference to unveil the proposals today, Sharfstein said none of the proposals have been finalized and that the FDA will solicit comments on them over the next 60 days. Some of the proposals could face legislative or funding hurdles, which would be addressed later, he added.
"We're really focused on the right thing to do. That's the first bridge to cross," Sharfstein said.
The draft proposal on food imports says the FDA should share the findings of its evaluations of importers or third parties that work on behalf of importers. It says that disclosing the results of the evaluations might discourage firms from misrepresenting products they import into the United States and that other federal agencies and supply chain companies need to know compliance histories.
The task force also said the FDA should regularly share basic information about facility inspections it conducts and the result of each inspection. Routinely sharing the information could give the public a clearer understanding of the FDA's role in protecting public health and would make firms accountable not just to the FDA, but to the larger public.
The information would also give other firms more information about the companies they choose to do business with, the group said. "Market pressures may create incentives for firms to correct violations quickly or prevent violations from occurring in the future."
The group also proposed that the FDA regularly summarize information about the most common violations linked to the products the agency regulates, which could serve as guidance for firms to use in their compliance efforts.
Three of the proposals address product recalls. The task force said the FDA should disclose safety-related information as quickly as possible when companies initiate recalls. To do so, the agency will need more recall authority that would allow it to require firms to share detailed information about the product.
"The FDA is in the best position to ensure that useful, actionable information is provided to the public about a problem with an FDA-regulated product so that consumers can make informed decisions in response to a recall announcement," the group wrote. "In addition, with ready access to key information about a recalled product, healthcare providers can better evaluate a patient's condition and provide appropriate care."
Other proposals would allow the FDA to share information about products that are not implicated in the recall, with the aim of reducing public confusion. The report said the FDA should let the public know when a recall is terminated. "It is also important to alert the public when the risk has passed and there is no longer a hazard posed by a specific product," the task force wrote.
At today's press conference Sharfstein said Hamburg will decide which proposals will take effect, on the basis of the public comments the FDA receives. He also said the FDA is working on draft transparency proposals for regulated industries. The task force is reviewing public input and will put issue a draft report later this summer, he added.
See also:
May 19 FDA press release
FDA transparency draft proposal report
May 19 N Engl J Med report
