February 04, 2003
At a Merrill Lynch conference in New York, FDA commissioner Dr. Mark McClellan spoke about three key regulatory issues:
- improving communication between the FDA and drug development companies
- accelerating the approval process
- minimizing misleading advertising.
McClellan wants not only to improve communications with drug development companies, but also to improve transparency for the general public, including investors, seeking to evaluate the prospects of drugs in development. He hopes that improved communication at both levels will both foster the FDA’s transparency and also discourage deceptive corporate communications. McClellan also indicated his desire to revise the FDA’s relationship with the Securities and Exchange Commission in such a way as to discourage such deception.
McClellan hopes to address corporate claims that the FDA has been unclear about the precise requirements and objectives for drugs in clinical trials. McClellan plans to enact new standards and publish new guidance addressing this issue. This effort would be undertaken in conjunction with the National Institutes of Health and independent clinical experts.
McClellan believes that by increasing the clarity of the regulatory review process, the FDA may be able to speed up the drug approval process. Although not highlighted at the meeting, McClellan also advocates the use of pharmacogenomic strategies to optimize clinical trials. Correlation of patients’ genetic variations to clinical outcomes could help bring certain drugs to market more rapidly and efficiently.
Punitive action for companies that persist with misleading consumers also appears at hand. McClellan cited several examples of companies’ receiving minimal punishment for deceptive advertising. Injunctions and fines appear to be only the tip of the iceberg under consideration in this regard under McClellan’s leadership.
Increased transparency at the FDA would be positive to both biotech companies and investors, and appears to be a manageable goal. McClellan’s other proposals, while positive for the biotech sector, will be more difficult to realize. Increasing the rate at which drugs are approved is a particularly difficult goal. We feel that the greatest impact in this regard can be made by the application of pharmacogenomics to clinical trials.
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