Federal law does not require release of drug testing data

Despite claims by Public Citizen Health Research Group that the public’s strong interest in protecting future drug test subjects outweighs the commercial preferences of drug companies, the U.S. Court of Appeals in Washington, D.C. (D.C. Cir.) ruled in early August that the Food, Drug and Cosmetic Act does not require disclosure of test data and that the proprietary exemption to the Freedom of Information Act protects such data from disclosure.

A law designed to protect subjects of drug testing requires the FDA to disclose information in its new drug applications. Public Citizen wanted more information about the tests that resulted in death or serious injury, causing the drug companies to abandon the drugs altogether.

Public Citizen Health Research Group sought information in July 1993 on drug testing that had resulted in deaths or serious injuries, or otherwise had caused drug companies to abort the study of a drug for reasons of health and safety.

The public interest group filed a Freedom of Information Act request with the federal Food and Drug Administration for Investigational Drug Applications, the forms drug companies submit to the regulatory agency in order to gain approval to test new drugs on humans. It specifically sought information in FDA files on the studies abandoned by the drug companies because of health and safety reasons.

The forms it requested are not the same as the New Drug Applications that companies submit to the FDA for approval for marketing. Those later applications, which detail studies of the drug and include summaries of testing on humans, routinely are disclosed.

What Public Citizen wanted were records of studies gone wrong, tests abandoned by the drug companies for safety reasons — because they had serious, adverse effects on humans, or because the company determined, from further testing on animals, that the drugs were simply too dangerous to test further.

After the agency first claimed that Public Citizen had not “reasonably described” records it sought, and then that it did not have the information “in a central file” where it could be located, Public Citizen filed a complaint in federal District Court in Washington, D.C.

In February 1996, the court ordered the agency and public interest group to reach an agreement on the search the agency would conduct.

FDA then identified 14 files responsive to Public Citizen’s request, but it did not provide them. In September 1996, the agency denied access to all files, saying disclosure would cause substantial competitive harm to the drug companies that had submitted them. It invoked Exemption 4 to the FOI Act, which protects information submitted to the government when disclosures would cause substantial competitive harm.

However, to avoid a court challenge, three of the drug companies withdrew any objections to release, and a fourth reached a settlement agreement with Public Citizen.

Public Citizen asked the court to order release of the six remaining files, five of which described tests abandoned by Schering Corp., which entered the lawsuit to argue, along with the FDA, that information on its abandoned drugs must be withheld. Schering had stopped its studies of three antifungal agents, a hypertension drug, and and a drug to suppress allergic inflammations and asthma.

Public Citizen told the court that the agency had not shown how these disclosures could cause any substantial injury to competition. It also pointed to the requirement of the Food, Drug and Cosmetic Act for disclosures of safety data except in “extraordinary circumstances.”

Certainly, the exception to disclosure for “extraordinary” circumstances demands a better reason than competitive harm if disclosures could keep another company from repeating danger to humans, Public Citizen said.

Schering told the court that disclosure would allow another drug company to develop a competitive product faster. For instance, a competitor could examine Schering’s judgment that a fungal malady merits the development of a drug; look at the early stages of multi-million dollar asthma and allergy projects; and provide competitors with elaborate research models for hypertension based on studies the company had conducted.

The company said the extraordinary circumstances exception to disclosure applies when “no work is being done” to have an application approved. The law does not require disclosure of safety data here because the exception fits, Schering said.

The FDA similarly argued that the competitive harm exemption would apply. However, it did not argue that the law requiring disclosure of safety information only applied to active drug applications. FDA’s regulations covered the whole application process during drug testing.

In March 1998, federal District Court Judge Royce Lamberth ruled for Public Citizen. Schering had shown that disclosure could cause it competitive harm, he said, but the language in the Food, Drug and Cosmetic Act, a later statute mandating disclosure, was intended to give the public insight into the dangers of drug testing.

Lamberth pointed to conflicting language in the legislative history of the 1984 food, drug and cosmetic law, but he followed explanatory notes in the record by Rep. Henry Waxman (D-Calif.) that “competitive harm” as protected by the FOI Act does not constitute an extraordinary circumstance that would allow nondisclosure.

The FDA and Schering appealed to the U.S. Court of Appeals in Washington, D.C. (D.C. Cir.).

Schering told the appeals panel that the food, drug and cosmetic law requiring disclosure of safety information does not apply to the requested forms. That law only requires disclosure of the drug company’s application to manufacture a new drug. Earlier forms for testing may be incorporated into that application, but there is no requirement for disclosure of forms on drugs that are tested and abandoned, Schering said.

The company and the agency reiterated their arguments that, even if the law applied, the substantial likelihood that disclosure of the safety data from tests on abandoned drugs would cause competitive injury is an extraordinary circumstance, and the drug law does not require disclosure in the extraordinary circumstances delineated in the law.

Public Citizen countered that Schering showed only that any drug manufacturer’s research might cause competitive harm, not that Schering’s case was in any way “extraordinary.” The company had not even shown how its competitors could gain a competitive advantage from reading about drugs abandoned by Schering.

The food, drug and cosmetic law compels the disclosure of safety studies it said, even studies early in the process. Human testing may be well underway when the results of animal testing reveal a serious health threat. The public cannot know if FDA is monitoring the tests effectively if it cannot see the early data.

If the law does not stop another drug company from testing the same dangerous drug and needlessly endangering human trial participants, it does not really serve any purpose, Public Citizen said.

The public interest group said that even an exemption on competitive harm should be weighed against the public’s interest in disclosure. The public has a strong interest in ensuring that the FDA adequately monitors dangerous drug tests, it said. And that interest outweighs any proprietary interest of the drug companies.

In late September, a panel of the federal appellate court reversed the lower court. The disclosure provisions of the food, drug and cosmetic law do not require that safety data in these files on testing be disclosed, it said. The law only requires disclosure of safety information in applications to develop a new drug. Preliminary applications for testing drugs on humans are not covered.

The only disclosure mandate for these files is the FOI Act, the court said. And the proprietary exemption, Exemption 4, allows the FDA to keep confidential Schering’s abandoned antifungal and allergy and asthma studies. The court ruled, however, that the exemption did not protect the information in its early and abandoned study of a drug to combat hypertension.

The panel majority said it is irrelevant whether the public’s interest in the records outweighs the proprietary interests of the drug companies. The court may not “gauge whether the competitive harm” of disclosure “is outweighed by the public interest in safeguarding” human health.

Concurring Judge Merrick Garland said the majority should not have ruled against a balancing of public and proprietary interests in making the decision on disclosure without further briefing and examination of the issue.

Citing the U.S. Supreme Court’s ruling in Department of Justice v. Reporters Committee, Garland said that a major purpose of the FOI Act is to shed light on an agency’s performance of its statutory duties. If the public can learn something about the effectiveness of FDA oversight of clinical trials in which death or serious injury occur, it will learn something directly about the workings of government, he wrote. (Public Citizen Health Research Group v. FDA)