Transparency groups: Long-standing FDA redactions policy violates Freedom of Information Act

WASHINGTON – A federal policy that allows the Food and Drug Administration to withhold key details about drugs, medical implants and other products is coming under new pressure from open government advocates.

A coalition of public interest groups asked the FDA on Friday to overturn the decades-old policy used to black out sections of federal documents before turning them over to journalists, investigators and others who request information from the government.

In a letter to the agency, says that the FDA’s so-called “minor deletions” policy is illegal and undermines the Obama administration’s goal of making government more accountable.

“It is impossible to square the deletions policy with the President’s stated commitment to transparency,” said Patrice McDermott, the group’s president, in the letter obtained by The Associated Press. The letter comes a few days before the start of Sunshine Week, when transparency advocates promote freedom of information.

McDermott asks FDA Commissioner Margaret Hamburg to take action on a formal petition from Public Citizen that would do away with the deletion policy. The consumer advocacy group, founded by Ralph Nader in the 1970s, submitted the petition in September, but has not heard from the FDA. Public Citizen is a member of the coalition.

Over the years, Public Citizen has drawn attention to dozens of drug safety issues by requesting FDA documents on patient side effects and clinical studies. In the case of the arthritis drug Bextra, Public Citizen’s disclosures brought to light information about blood clots that led to the drug’s market withdrawal in 2005 due to concerns about stroke and heart attack.

Public Citizen says the FDA has repeatedly redacted large portions of text from documents, in some cases blacking out a half-page or more.

The agency justifies this approach in its staff manual, saying that: “The overwhelming majority of requesters who receive documents with minor deletions are satisfied and do not request withheld material.”

Regardless of whether most requestors accept the deletions, Public Citizen and other critics say the FDA is still ignoring the law. In 1991 the federal government’s own watchdog arm, the Government Accountability Office, urged the FDA to do away with the policy, saying it conflicted with the Freedom of Information Act.

Under that law, anyone who seeks information from the federal government is supposed to get it unless disclosure would hurt national security, violate personal privacy or expose business secrets or confidential decision-making in certain areas. If any information is withheld, the government is supposed to give the requester an immediate option to appeal the decision. But the FDA requires requesters to make a second request to release the redacted information. Only after this second request is denied does the FDA inform the person of their right to an appeal.

Some FDA documents contain proprietary company information about drug testing or manufacturing techniques. The FDA claims the deletions policy actually benefits the public because it allows the agency to release documents that might have to be withheld indefinitely if they were not redacted.

But the agency’s critics say the policy is simply an extra logistical hurdle that is unprecedented in the federal government.

“The steps that the FDA has created leave requesters in a state of limbo and add a procedural barrier that is neither lawful nor necessary,” said Julie Murray, an attorney with Public Citizen who worked on the petition.

Murray said the deletions policy also distorts the FDA’s record of compliance with the Freedom of Information Act, which it must report annually. In 2011, the FDA reported that 97 per cent of the documents it released under the Freedom of Information Act were “full releases.”

That number is higher than any other agency in the Department of Health and Human Services, which includes the Centers for Disease Control, the National Institutes of Health and other institutions. But Public Citizen says the FDA’s figure is likely inflated since the agency apparently doesn’t count “minor deletions” as withheld information.

An FDA spokesman said this week that the agency is still reviewing Public Citizen’s petition. Under FDA rules, the agency has 180 days to respond to petitions, placing a March 19 deadline on the group’s request.