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Recent Articles
Rx Industry's Black Box, Part II
Reuters corroborates this GoozNews post last week suggesting investors will be getting less information when the Food and Drug Administration eliminates its "approvable" or "non-approvable" label on letters sent to firms whose experimental drugs do not yet meet new drug approval requirements. The news analysis claims "the new process could prompt more shareholder lawsuits, if companies disclose little about the FDA responses."
Not to worry, Alan Goldhammer of the Pharmaceutical Research and Manufacturers Association told the news agency. Drugmakers "have been fairly transparent when they get these letters (about) what the letters mean," he said. Oh really? Then what about Schering-Plough's 447-word press release on the FDA's rejection of sugammadex, which contained all of six words ("primarily related to hypersensitivity/allergic reactions") on the agency's reasoning. Or all of the other examples offered on the Forbes Magazine website, which broke the story?
If the FDA cannot release these letters because it is prohibited from doing so by Congress, and the companies won't release these letters, then it is time for the Securities and Exchange Commission to act. This information materially affects share prices, and that means it must be disclosed to investors. This is one case where shareholder interests and public health are clearly aligned.
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Comments
Not only does the contents of the letters need to be released but Congress really needs to specify what goes into these letters.
I have seen a number of these letters and even if they were to be released they are typically written in such a way so as to be misleading.
Congress needs to specify that:
1. Deficiencies need to be categorized into major (i.e. precludes approval and extensive additional work needs to be done (estimated > 6 months) and the deficiencies are so great that they may not be able to be overcome. Moderate a resubmission within 6 months is possible. Minor only further negotiations over labeling are needed (should be resolvable within 2 months).
2. They must state whether each deficiencies relate to A. Efficacy or B. Safety and spell out precisely what the deficiency is.
3. Each deficiency must state exactly which section down to the specific clause of the Food Drug and Cosmetics Act precludes approval and the specific reason(s) (for that particular drug) and the clause itself must be explicitly spelled outin the letter.
4. The letter must spell out exactly what needs to be done to address each deficiency.
5. Each primary reviewer and review discipline has final signoff on it's area of review and shall prepare it's section of the letter with no override or editting from the clinical division or(as they aren't qualified). Also since reviews are crossdisciplinary a review discipline (e.g. medical or clinical pharmacology or statistics or chemistry or toxicology) may specify deficiencies in another area that impacts them but they may not override and minimize deficiencies identified by another review division.
All supervisory signoffs must explicitly agree or disagree with reviewers and if they disagree a memo to the file from the disvision director (not the team leader) must be included with justification(s) for disagreement. Plus reviewers must have a chance for rebutal.
All of this must be publicly available, including the original reviews and all documents, letters, and communications.
Salmon
Have you submitted these suggestions to Congressional oversight committees? If current law prohibits FDA from releasing pertinent information--the laws can and should be rewritten. Despite the alignment (in this case) of shareholder interests and public health, those who oversee our regulators need to do their jobs and empower regulators to operate in the best interest of CONSUMERS (patients)--not corporations.