Thought Leaders: Tapping the Free Flow of FDA Information

Mar 01, 2005
By Pharmaceutical Executive Editors

The Freedom of Information Act (FOIA), signed into law by Lyndon Johnson on July 4, 1965, theoretically gives the public access to US government records. But in actuality, enforcement was lax until 1975 when the act was strengthened in the wake of Watergate. As government compliance with the law increased, so did pharma companies' concerns. They began to wonder what FDA documents requested under the act might reveal.

These days savvy companies actively use FOIA as a competitive intellligence tool, both to track what competitors are doing, based on their interactions with FDA, and to monitor what other companies are learning about them.

Pharm Exec: What kind of information must FDA disclose and what can it keep secret? Bobka: Theoretically, FOIA opens everything to scrutiny. There are just nine legal exemptions (see Exceptions to the Rules sidebar). Keep in mind, many of the documents that are released are redacted—some would say censored. They can be ugly. First off, FDA uses a photocopier running on a drop of toner. Then someone with a black magic marker obliterates the exempt sections. In the old days, we would get microfiche that had been carved by someone with an X-acto knife so they looked like lace doilies.

Exceptions to the Rules
The exemption of most interest to pharma is Exemption Four, trade secrets. FDA interprets that to include pipeline products. The agency will not even acknowledge they have an Investigational New Drug (IND) Application because the development of a drug is considered a trade secret. So FOIA is a lousy way to research another company's pipeline. However, FDA can make an exception if the company has issued a press release saying, for example, "Our new product is wonderful for such-and-such indications." FDA can then confirm or deny that claim, if information on the product was submitted. But, generally, until a product is approved or denied—whether an IND or a New Drug Application (NDA)—FDA won't discuss it. That is one reason companies withdraw a product approval application if they foresee it will not be okayed. Because as soon as a decision is rendered—yes or no—the project is no longer subject to Exemption Four and information is liable to become public.

What kinds of competitive intelligence are companies interested in obtaining? When FDA inspects a plant, the investigators write an Establishment Inspection Report (EIR). If they find anything out of order, they also prepare a form, FDA-483, which starts, "During this inspection, I/we observed...," and goes on to list things FDA thinks need attention. All that is interesting in itself. But even better is the accompanying narrative, which usually tells the history of the business, who reports to whom in upper and regulatory management, the shape the business is in, whether they are operating in a state of control (in compliance with good manufacturing practices), and so on. Then it details what inspectors examined. Some companies obtain EIRs for due diligence, when they are buying another company or forming a joint venture. Those planning to hire high-level regulatory personnel might want to see how candidates interacted with FDA. Business development and marketing departments use EIRs. If you're selling contract manufacturing, you can see what kinds of problems a target company has and how your services could help them. Finally, we at FOI Services index EIRs by FDA investigator. So when a company expects a certain investigator to visit, they can review her past inspections and see if she's interested in, say, water for injection (WFI) or computer validation.

What else is FOIA good for? If you go back to the original idea behind FOIA, which was to let reporters and others have a clear view of what their government does—sunshine, as they like to say, is the best disinfectant—FOIA requests can provide valuable insight into how FDA itself operates. At times, the agency can be mysterious. But you can look at what FDA has done in certain situations in the past and let that guide your future dealings. Say you have a generic product. You can determine how FDA reacted to studies submitted by others for similar products. It may help you design your bioequivalent.

Correspondence between FDA and industry players are often disclosable and potentially revealing. You can almost interpret what agency staffers were thinking in various situations.

Finally, CVs of FDA personnel can tell you what areas reviewers and investigators have a particular interest in. Or they can help if you're attempting to hire a former agency employee.

Are FOIA inquiries themselves subject to FOIA? Yes. A FOIA request is a matter of public record. The reason people come to us rather than make their own requests—anybody in the world can submit one—is two-fold. One is it takes a long time, between six weeks and three years, to get a response. We once cancelled a request after waiting seven years for a response. But we already have 200,000 documents and 7.5 million pages in our archives. So if a client wants something we've already requested, we can deliver it immediately. The other issue is confidentiality. If ACME Pharma is researching XYZ, XYZ can learn exactly what ACME is asking for. So ACME might use an intermediary as the requester of record, as a kind of blinding. What's more, as a private company, we are not forced to reveal our clients.

Is this kind of information easier or more difficult to come by than, say, five years ago? Both, actually. The web has certainly helped distribute guidelines and other instructive documents. On the other hand, FDA's funding is not keeping up. Preparing a response to a request for information under FOIA can be quite expensive. A document has to be located then reviewed for exempt information. So there's been a slowdown at FDA due to a lack of resources.

In your view, are the exemptions reasonable? Yes. Considering the volume of requests, FDA's adherence to regulations—particularly not disclosing confidential information—is admirable. They have to be careful about medical information—for example, anything under the Privacy Act—and remove patient identifiers. In the case of adverse drug reactions (ADRs), the identity of the person who reported the ADR has to be obscured. So FDA does a superb job of walking a fine line.

Marlene Bobka is vice president of FOI Services, a Gaithersburg, Maryland-based company that has been providing clients with FDA documents for thirty years. She began her career as an information specialist by combining undergraduate training in biology and chemistry with a masters degree in library and information science. She has worked for the National Cancer Institute and BRS Information Technologies. Her responsibilities at FOI Services, which she joined in 1985, include marketing and information service activities. She has addressed the Regulatory Affairs Professional Society, the Special Libraries Association, AdvaMed, and the American Chemical Society.

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