I urge you to send a letter to the Food and Drug Administration (FDA). It has come to my attention that the FDA is now allowing pharmaceutical manufacturers to withhold "non-serious" adverse reaction reports. This places the bulk of post-marketing adverse reaction reports out of reach with Freedom of Information requests.

Implementation of this new policy will make it virtually impossible to track post marketing reactions, developing syndromes, and various side effects. This will have a potentially deadly impact upon patient safety.


Sample Letter

Michael A. Friedman, M.D.
Lead Deputy Commissioner
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

Dear Dr. Friedman:

I am writing to express concern about a new FDA policy which would deprive clinicians, medical researchers, forensic examiners, the public, the press, and the legal community of important safety information about adverse reactions from approved drugs and biological products.

In a "Guidance for Industry: Postmarketing Adverse Experience Reporting for Human Drugs and Licensed Biological Proudcts (August 1997)" the FDA states that it is prepared to waive submission of adverse expereince reports for "nonserious", labeled adverse reactions.

This policy is harmful to the public health for the following reasons:

1. The public would lose access to important safety information about drugs. Although the FDA and the sponsor would still have access to the data, this would reverse a long tradition at the FDA of providing wide public access to its data, deliberations, and decisions.

2. Adverse events classified as "nonserious" may in fact be related to very serious events. For example, "heart palpitations" may signal cardiac effects with lethal effects in other patients. "Nausea" under some conditions may indicate liver damage or gastric ulceration. "Itching" or "rash" may indicate potentially lethal anaphylaxis in some cases.

3. Nonserious labeled events may be disovered as part of a larger syndrome with serious health implications. Ohter nonserious events such as sexual dysfunction, congnitive impairment, suicidal ideation, and hallucinations may not technically be "serious" but are of great public importance.

4. A policy of granting waivers in scattered cases would seriously undermine the integrity of the Spontaneous Reporting System data base and its planned successor. Individuals inside of, or outside of the FDA attempting to use the data could not know whether it included all the reported adverse events, or just some of them. It is hard to imagine a more harmful approach than this inherently non-uniform, inconsistent policy of granting waivers to some companies. This would render the database unusable for some kinds of analysis currently performed.

5. The savings to industry would be trivial. While the public would lose valuable information, industry would not gain much since it must continue to collect, investigate and provide this information upon FDA request.

6. Incentives to develop safer drugs would be reduced. While a drug's sponsor would continue to have complete information on the side effects profile of its own products, competitors seeking to develop drugs with fewer risks would lose access to this information.

7. Conditions for granting the reporting waiver are not stated laying the groudwork for abrbitrary and inconsistent decisions.

8. It provides an incentive for abuse of classifications because a serious event deliberately classified as "nonserious" would not have to be reported to FDA and would unlikely to be detected.

Despite these objections, it is important to weigh the benefits as well as the harm of a proposed public policy. In this case, there are few apparent benefits to reducing the completeness and timeliness of adverse effects data. The FDA might save a small amount in data entry costs. But with the growing electronic submission of data, even these savings will be tiny, or in future years, non-existent.

One hopes that FDA policy is not based on the idea that once adverse effects are listed on a drug's product labeling, they are of no further interest to the agency, the research community, or the public. Such data is essential to public safety. It is important for comparative purposes in evaluating newly approved drugs. It is useful in monitoring whether clinicians and consumers are learning of drug risks and taking appropriate action to minimize them. The data provides essential baseline for comparing adverse reactions reported to FDA to those actually occurring.

At a time when advancing information technology makes it faster and cheaper to collect, store, and disseminate information, the FDA should be taking the lead in increasing the information available about the safety of drugs and biologicals rather than subjecting the now available data to needless restriction.

May I respectfully suggest that the FDA postpone granting waivers under this new policy until such time as this initiative receives more complete public scrutiny and debate.

Sincerely,



Peter D. Anderson, R.Ph., DABFE, FASCP, Pharm.D. Candidate
Clincal & Forensic Pharmacist


cc: Janet Woodcock, M.D.
Director,
Center for Drug Evaluation and Research

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