April 3 2002 letter to FDA Commissioner requesting public consideration of the disclosure regulations
Lester Crawford, DVM, PhD
Office of the Commissioner
Food and Drug Administration
Via e-mail and fax
Dear Dr. Crawford,
Recent events in the oncology drug development world and the resulting scrutiny of the FDA drug approval process offer the FDA an opportunity to improve this process.
ImClone Systems received an FDA "Refusal to File" (RTF) letter for its Erbitux application on December 28, 2001. Until The Cancer Letter obtained its copy of the RTF letter, the public had no way of understanding why the Erbitux application was refused by the FDA. Similarly, Corixa Corporation received an FDA "Complete Review Letter" on March 15, 2002 for its Bexxar application. However, this letter was not leaked to the press, and therefore, we -- both the general public and, most importantly, patients waiting for drug approval -- are left in the dark about the facts behind the FDA's decision.
If, for example, the FDA halts cancer research on patients for whatever reason, current regulations permit the FDA to communicate only with the drug sponsor, usually a company or academic institution. This means that trial participants and patients making clinical trial choices can get their information only from the sponsor. The FDA cannot correct misinformation or offer their perspective on the problems in the clinical trial to anyone without the sponsor's permission.
Similarly, when an unapproved drug gets in trouble because of its clinical trial design, investors and, much more importantly, the patients are not usually aware of this trouble until the FDA turns the drug down. Even then, if the FDA does not choose to discuss the disapproved drug at an FDA public advisory committee meeting, the public may never know why the drug was not approved. A drug company might disclose vague information about the trouble their drug has encountered, but if this information is misleading, the FDA is prohibited from refuting the drug company's account.
These situations are not unusual due to the proprietary information regulations as defined and enacted by the FDA. The FDA regulations prohibiting disclosure of proprietary information were intended to protect corporate trade secrets and financial information. This prohibition has created an impenetrable shield behind which the FDA and drug companies hold their discussions.
We believe that it is time to review these regulations, with an eye to increasing public availability of information at certain critical times in the drug approval process. We find ourselves in agreement with a portion of the Wall Street Journal editorial of March 22 2002, that "the solution is ...for the FDA to disclose more about its drug reviews, as guidance to both investors and patients. People shouldn't have to wait for leaked letters to understand what the bureaucracy is up to ..."
The FDA is charged with protecting the public. We therefore believe fulfillment of this charge should require the FDA to permit appropriate public disclosure of necessary information to patients without compromising proprietary interests.
Given all that has happened in the past several months, we believe that the FDA must be thinking about this issue. We therefore would like a response to the following question:
Will the FDA consider a revision to public disclosure regulations?
The time has come for the FDA to initiate a public discussion of the conflict between a patient's right to know and a sponsor's right to protect their proprietary interest.
Thank you for your prompt consideration of, and response to, our concerns. We look forward to hearing from you.
Bob Erwin Marti Nelson Cancer Foundation
607 Elmira Road PNB 331
Vacaville, CA 95687