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By Brian Reid

June 12, 2002 | The FDA’s Web site (www.fda.gov) is a treasure trove of information. Want transcripts of any agency public meeting? They’re posted there. Electronic copies of nearly every piece of mail the FDA gets from citizens? Posted there. Company trade secrets? They might just be buried there, too, according to a petition filed in March by a tiny drug maker.

Jerome Stevens Pharmaceuticals Inc. asserts that the FDA published confidential information about its thyroid drug on the agency’s portal to the Internet for five months, representing an unprecedented breach. Before the posting, only three people knew the company’s method of keeping its drug, Unithroid, stable. Now, countless people could have accessed the information. “At this point, the damage is done,” says Ronald Steinlauf, vice president for the 16-employee company based in Bohemia, N.Y. The company has threatened legal action if the FDA does not agree to stay the approval of drugs that appear to use the Jerome Stevens information.

The stakes for Jerome Stevens are enormous. Unithroid is a version of a drug known generically as levothyroxine sodium, which has been used in patients with hypothyroid disease for decades. The best-selling version of the drug, Synthroid, has been in use since 1955 and is the third most-prescribed drug in the United States.

Because the drug was introduced before much of the FDA’s regulatory structure was established, no levothyroxine sodium drug ever needed approval until recently. The change came in 1997, when the FDA said it would require makers of the drug to formally apply for approval, citing a history of unresolved quality-control problems with the drugs. In August 2000, Jerome Stevens was the first to win approval for a levothyroxine sodium drug. That could have given the company control over the market if the FDA had moved to pull other levothyroxine sodium products from the pharmacy shelves -- a decision it could have made according to its original pronouncement. The agency has not taken that step, however.

The Internet problems apparently arose the day after the FDA approval was granted, according to the company’s petition. On August 22, 2000, as is standard practice, the FDA posted the drug’s “approval packet,” the group of documents used to vet a drug being considered for approval. Prior to posting, any such packet is supposed to be combed for information that is considered a trade secret or confidential. In the case of Unithroid, however, the secret data was placed on the Web without reaction. It wasn’t until mid-December of 2000 that the company discovered the problem. Ironically, the person who stumbled onto the posting was the one company scientist who knew the secret. Needless to say, “he was shocked,” says Steinlauf. It took another month to get the offending material removed from the site, according to the company’s petition.

“It’s either intentional misconduct or gross negligence,” says Jonathan Emord, the lawyer who drafted the petition for Jerome Stevens. “It takes a conscious effort to do what they did.”

The FDA declined to comment on the company’s petition.

Because this appears to be the first Web-related snafu involving trade secrets, the agency is likely to stay quiet on the topic, according to Ira Loss, a stock market analyst who follows the FDA for Washington Analysis. “They’re not likely to say much, because they’ll get sued,” he says. “They’re not clear what their liability is.”

The agency’s Manual of Policies and Procedures outlines the way the FDA is supposed to go about posting documents. The very first point of that policy notes that documents must “have received proper clearance,” adding that “only information that is disclosable to the public will be placed on the … Web site.” Before posting information about specific drugs, FDA officials must take the additional step of gaining approval from the agency’s Freedom of Information Act (FOIA) Office. Emord says it is still not clear where the FDA erred.

Problems with the dissemination of information are not new to the FDA, note agency-watchers, though the problem is more often the dissemination of too little information than too much. Larry Sasich, a pharmacist at the citizen’s advocacy group Public Citizen, points to a small FOIA staff that’s probably swamped by the avalanche of documents that now go up on the site. “The FOIA office probably suffers [from] a lack of resources,” he says, noting that the office has historically been understaffed and generally relies heavily on low-level employees. “I would think it’s a very difficult job.”

Brian Reid is a freelance writer based in Alexandria, Va.

 





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