Like a collision on the 405, 2010 has been an interesting year to say the least. It’s one of those years, the ones people gawk at as they drive past, wondering what happened. Though you may be unaware of the cause, you are affected by the result. Let’s take a bit of time to reflect now that it’s close to being in our rear-view mirror.
FDA: It has been a busy year at the agency. New staffing, questionable scientific review, recalls, warning letters, and enforcement actions with an assertion of transparency.
New Dietary Ingredients came to the forefront with the agency working with some and against others forcing recalls and closures of facilities operating outside DSHEA. Among many problems with DSHEA; the regulation that covers dietary supplements and ingredients (and has since 1994); is that corporations are the ones that are left to decide whether a dietary ingredient is new or not. Often a difficult endeavor, as the regulation and its enforcement is often vague even for ingredients that have been in the American diet for generations. As a user of supplements since my teen years, and self-professed gym rat, I am all for tighter regulation as long as it doesn’t interfere with freedom of choice to supplement or not supplement. Expect in 2011 much tighter regulation and more supplement recalls.
Food Safety has become a prominent focus, after a year plagued by contaminated food, congress passed the Food Safety Modernization Act just last week. It remains to be seen how this will affect the industry, and whether and how the FDA will enforce the regulation. It will force all food processors to register with the FDA, and establish hazard and risk based analysis of their products. Current thought is that this may indirectly affect the supplement industry since all supplements are considered food; however these facilities already follow the more onerous cGMP guidelines (or should).
New 510k guidance, no REALLY it’s coming we promise. After almost a year of threatening to release new guidance regarding the 510k process, it seems more imminent for early 2011. Santa has delivered word that CDRH reviewers are actually training on the new guidance and its implementation. This will extend the review process and increase the safety assessments necessary for these devices based on previously approved predicates; read increased cost to get through the device approval process. The implementation of a more stringent safety review is a necessary evil considering the increases of late in the number of Class I and II device recalls (DePuy, ev3, Medtronic, and others).
Avandia. In what some may consider a more political action, the agency essentially forced Avandia off the market for reasons that seem to escape scientific logic, even that of FDA’s own medical reviewers. Though the clinical data is ambiguous on the relationship between Avandia and increased cardiovascular risk, especially since most diabetics also have cardiac complications due to the disease, the congressional pressure was not; forcing the FDA’s hand in protecting the public from the perceived risk.
Overall FDA enforcement has increased in 2010, make no mistake, this is a good thing for the industry and the consumer alike. The FDA has also made an attempt to be more “transparent” with the introduction of the FDA Transparency Blog and an effort to rate itself against metrics. More accountability in government is definitely a step in the right direction. At the end of the day, the increased safety evaluations required for new drug and device approvals, as well as enforcement of supplement and food safety should lead to a clearer path to regulatory approval, and a more compliant market–one can only hope.
Health Care Reform–Obamacare
Apart from the propaganda serving as public service announcements from the Department of Health and Human Services, this law will inevitably change the medical landscape in some major ways. Reimbursements for medicine, devices, and care are expected to decrease under the plan forcing a first-class assault on the research and development costs required to push new therapies into the marketplace. The already laborious process associated with approval and the clogged approval pipelines are about to come to gridlock as approval becomes more difficult, and more therapies are submitted to an already overtaxed agency due to the limitations placed on drug costs; further placing indirect limits on innovation and exacerbating an already detrimental effect on the industry and U.S. healthcare.
Overall, 2010 has produced changes that will reverberate throughout the biomedical industry for years to come. Here’s to a new productivity in 2011 that will introduce sanity and science into the process and the prevailing of more reasoned thought.
- FDA Targets Tainted Dietary Supplements (webmd.com)
- Is It Really FDA Approved? (everydayhealth.com)
- CAM and the Law Part 4: Regulation of Supplements and Homeopathic Remedies (sciencebasedmedicine.org)
- FDA Eyes Overhaul of Medical Device Regulation (dailyfinance.com)
- “FDA Steps Up Efforts Against Tainted Products Masquerading as Dietary Supplements” and related posts (fdalawblog.net)
- FDA Cracks Down on Weight-Loss, Sexual-Enhancement Supplements (aolhealth.com)
- Tainted Products Marketed as Dietary Supplements (nlm.nih.gov)
- FDA Restricts Access to Avandia (everydayhealth.com)