Newly confirmed FDA commissioner Dr. Margaret Hamburg indicated In a recent speech ways that the agency will step up enforcement activities.
So put on your seatbelts. We’re going to see just how much the new mantra of “transparency” will help or further hinder the commercialization of medical products.
Hamburg announced several initiatives during her talk, including post-inspection deadlines of 15 working days for FDA to outline its issues for industry before a warning letter will be sent and limiting warning letter reviews to “significant legal issues.”
Someone asked if she could be clearer about how the FDA would define that, and the answer was, “it will depend.” The agency plans to work more closely with local, state and international sister agencies, but she never once mentioned the FTC — the lone agency charged with oversight of advertising of unrestricted medical devices.
There will be greater prioritization of FDA enforcement activities (warning letters or recalls). In the food arena, the agency will now have mandatory recall power. It will no longer wait to see if industry will comply with their concerns and will take possibly immediate action with or before a warning letter issues. The agency will increase its efforts to monitor adverse events and act more quickly if it determines that these events pose significant safety risks to the public. Finally, when a firm has satisfied the FDA’s conditions, they will send the company a post-closing letter and post it on its website.
Congress has awarded the FDA with more funds to execute these plans; the commissioner is certainly qualified to lead the agency, bringing her medical experience and research background to the job.
But she appears enthusiastic but naïve where industry is concerned. I applaud her efforts to take down companies making fraudulent claims that their unapproved drug for body building is really a dietary supplement. If the company is really putting out a drug without clinically valid data that might confuse the consumer, action should be taken to get that information clarified or take the product out of circulation. Equally important are the 65 warning letters issued after the Swine Flu outbreaks began. Companies made claims that they had devices that might diagnose H1N1, but these were not cleared by the FDA. Those types of swift actions are presumably warranted.
However, what about the responsible medical device companies? It’s already difficult, if not impossible, to understand the complexities of the Food, Drug and Cosmetic Act, not to mention the FDA regulations that may or may not attempt to demystify the law. The industry does not benefit from fraudulent or misleading advertising, or from false or misbranded labeling on its products. It is not in the FDA’s interest to over-regulate the industry. Such actions can dampen the spirits of entrepreneurs, or more importantly their funding sources.
Commissioner Hamburg should be speaking not only with the FTC but with Karen Mills at the SBA. From her, she can learn about the need for small business to not be over burdened with fees, compliance and enforcement responses that will limit the number of clinically needed products.
There is no question that the FDA has a role to play in protecting the public health. But the role of industry cannot be under-emphasized. Patent system reforms are providing enough of a roller coaster ride for many companies. Healthcare reform, when that becomes defined, will certainly have an impact on the types of and ways that a medical technology will be adopted, purchased, utilized and reimbursed.
Now, industry must be on the lookout for inspectors looking to make names for themselves or working to set up opportunities for the agency to define “significant legal issues” in the courts. All agree that bad products do not deserve to be in the marketplace. The industry needs to be able to police itself and report voluntarily to the FDA. In the past, the two-way street was closed or blocked off. Maybe Dr. Hamburg will continue her efforts to educate herself and will truly have the public health at heart. I remain cautious and will keep my seat belt fastened tight.
