Despite its moniker, the Food and Drug Administration (FDA) has been more drug (and device) than food in recent years.
One major reason: the agency competes with several federal agencies, including the Department of Agriculture and Environmental Protection Agency, to oversee the nation’s food supply. It’s a confusing and ultimately self-defeating tangle of bureaucracy and overlapping authority.
But when it comes to regulating pharmaceuticals and medical devices, there is no such confusion. And the FDA has not been shy about using its authority, sometimes to the detriment of the two industries.
A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Now this: the U.S. Senate Tuesday overwhelmingly passed a bill granting the agency broad new powers to police the food industry, including stepped up recalls, inspections and farm watching.
While most people can agree on the need for safe food, the bill is another example of what plagues the agency these days: expanded mandates with neither the resources nor institutional ability to do what everyone wants it to do.
Medical device advocates say the FDA already performs poorly with one of its primary responsibilities — approving new technologies and promoting innovation. Instead, the agency wants to partner with universities to “advise” makers of external defibrillators on… how to make external defibrillators.
The FDA may have misplaced priorities, but even medical device executives and agency officials can agree on one thing: the FDA sorely lacks money and staff. Speaking at town a hall meeting in Bloomington, Minnesota earlier this year, Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health, admitted the agency is not keeping pace with its responsibilities.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The FDA has requested $4.03 billion for fiscal 2011 — a 23 percent increase over its previous year’s budget. But whether the agency gets that money is another matter, given the demands for financial austerity sweeping Washington, D.C. In fact, the White House is asking all agencies, including the FDA, to identify ways to cut budgets by 5 percent for fiscal 2012.
The bill cleared by the Senate doesn’t even provide a clear method to fund the FDA’s new responsibilities. The House of Representatives’ version of the bill requires food producers to pay a fee to fund inspections. But the Senate bill does not include that provision.
The FDA arguably can’t stomach the food(!) on its plate right now. Adding more courses doesn’t seem to make a whole lot of sense.
The agency, of course, could still prove it can walk and chew gum at the same time. But without extra help, the FDA is more than likely to choke.
