HealthpointCapital Interviews Gerald Masoudi, Co-Chair of the Food and Drug Practice Group at Covington & Burling LLP and Former FDA Chief Counsel: Part II
BY LAUREN UZDIENSKI, JUNE 16, 2009
Continued from yesterday, below is part two of our interview with Gerald Masoudi , a partner in Covington & Burling LLP's Washington, DC office and co-chair of the Food and Drug practice group. Mr. Masoudi most recently served as Chief Counsel of the Food and Drug Administration.
HealthpointCapital: How does the FDA review promotional materials and labels, and is that process changing or becoming more stringent?
Gerald Masoudi: Advertising and promotion of medical products raises interesting legal and policy issues. I'm firmly convinced that direct-to-consumer (DTC) advertising and other promotion improves patients' lives by giving them important information about effective treatments and by encouraging them to seek help for treatable conditions. It is important, however, that such advertising accurately present the risks and benefits of using the products.
FDA's Division of Drug Marketing, Advertising and Communication (DDMAC) regularly reviews print, web and television advertising for drug products. It looks for advertisements and promotional labeling that are misleading or otherwise fail to comply with FDA's regulations. For example, DDMAC may conclude that an advertisement fails adequately to disclose risk information, improperly broadens a product's indication, or uses visual cues that distract viewers from important information about the product.
DDMAC may then draft a Warning or Untitled Letter to the drug sponsor giving notice of a violation. Each of those letters is reviewed by the Office of Chief Counsel to ensure that the letter comports with FDA's regulations as well as with a company's First Amendment rights. Because companies have constitutional rights to disseminate truthful and non-misleading information about their products, this legal review is especially important. I therefore would expect that FDA will continue to involve the Chief Counsel's office in review of advertising and promotion letters.
DDMAC also reviews advertisements voluntarily submitted to FDA by companies and may provide comments -- which companies are encouraged but not legally required to follow -- in response to the submissions.
There are some signs that DDMAC may be growing more aggressive, as evidenced, for example, by the many letters sent in March on the subject of sponsored internet links by drug companies. Those letters take what I believe to be an aggressive approach to the subject of internet advertising. Overall, if those letters are taken into account, there have been as many violation letters sent in the first half of 2009 as there were in all of 2008. It will be interesting to watch the number and nature of violation letters sent on advertising issues.
HC: How is the agency defining comparative effectiveness, and what will it mean for companies?
GM: FDA assesses treatments based on its mandate to determine whether products are safe and effective when used as set forth in the products' labeling. "Comparative effectiveness," which refers to comparisons of the efficacy of competing treatments, is a concept that some believe is important for purposes of determining reimbursement, but is one that has no place in FDA's review of medical products. If a product is shown to be safe and effective in a target population, it should be approved by FDA, regardless of whether there is another treatment that is believed to be more effective in that population.
Putting aside the merits of comparative effectiveness research in the realm of reimbursement, I think it would be detrimental to the public and contrary to legal authority for FDA to engage in comparative effectiveness analysis as part of its review of drugs and devices.
HC: How did you interact with companies? Did you often meet face-to-face or work closely with individual companies?
GM: I was willing to meet with interested parties who wanted to discuss significant legal issues under FDA's authorities (if someone had what really was a scientific issue, I would leave that to the scientists and physicians at FDA to handle). I discussed legal matters with companies and their outside counsel, public interest groups and trade associations. These meetings might be about product approvals, product labeling, enforcement matters, or amicus briefs filed in litigation involving private parties. I found that it was very valuable for me to hear all perspectives on legal and policy matters. There were certainly times when meetings with outside parties changed my view on a legal issue or helped me to clarify the agency's position. I reported meetings I held with outside parties on a public calendar available on FDA's web site.
HC: What advice do you have for companies seeking product clearance or approval? What can companies do to be proactive in their relationship with the FDA?
GM: Companies who intend to seek approval or clearance should get advice from knowledgeable counsel early in the process of research. Even at the stage before research begins, a company should be thinking about and preparing for patent and clinical trial issues, and should have a strategy in place for not only bringing the product to market, but for acquiring appropriate reimbursement for the product and protecting the company's investment in its innovations through intellectual property protections. Throughout the approval process, it is important to maintain an open dialog with the agency to avoid unpleasant surprises and to ensure that the reviewers at FDA have the information they need to approve or clear the product. And if legal issues arise in connection with an approval, it is important to consider engaging with the Office of Chief Counsel to ensure that FDA is applying the appropriate legal standards.
