FDA Regulatory Requirements, Enforcement Activity Have Increased Despite Agency Acknowledging the Strain on Small Companies

We frequently cover FDA regulations—proposed rules, FDA explanations, the role of collaboration between industry and FDA in the regulatory process, and recently the sometimes complicated relationship between industry and FDA. It probably then comes as no surprise that business leaders across a number of industries are bracing for an onslaught of regulations in wake of the midterm elections and some of these policy changes involve FDA.

The Hill reports there are roughly two dozen major rules that are scheduled to drop before late January, according to a review of the administration’s official regulatory agenda and rules now awaiting approval at the White House. Specifically for FDA, agency officials are gearing up to push for menu labeling rules that could have a tremendous impact on the restaurant industry. Eateries could be required to post calorie counts on menus, which critics say could cost the industry billions of dollars.

Reports like this only increase long-held public and industry perception that FDA regulatory actions are increasing, and according to recent research, they would in fact be correct. Regulatory Focus recently analyzed data from George Mason University’s Mercatus Center. They found that FDA regulatory requirements have increased by 15% between 2000 and 2012. In 2000, there were 16,329 requirements, compared to 18,777 in 2012. The data also shows that sections of the Code of Federal Regulations dealing with FDA increased a total of 166,892 words between 2000 and 2012, which is an average increase of 11,920 words per year. You can check out the Regulatory Focus analysis here and more regulatory policy research data from the Mercatus Center at this link.

This increase in regulation, although not surprising, also corresponds with an increase in FDA activity, seen notably through the issuance of warnings letters.

It is interesting to see increased FDA regulatory action at the same time FDA Commissioner Hamburg has recently noted the need for the balancing of agency priorities. While preserving agency standards for ensuring medical products are safe and effective, FDA also wants to provide ways for patients to get new medical advances as early as possible. Hamburg has made providing “clarity and predictability” a priority in the FDA regulatory process, and as reported, she recently stated: “There’s more work to be done. Part of that has been to make more information available about what we do and how we do it.”

The weight of regulation is especially burdensome for smaller healthcare companies, so it was interesting that Hamburg specifically cited this concern in her recent comments. Smaller healthcare enterprises do not have extensive regulatory affairs departments and often less experience dealing with FDA rules. But Hamburg noted part of FDA’s responsibility is to “be as open as possible and to help companies engage with [FDA], provide them with support, and recognize the time and financial pressure on these companies.”

“We need to be as responsive as possible, she stated. “We need to be able to help guide fledgling companies through the process.”

These are important comments, and as always, we will continue to report on FDA regulatory developments and monitor their possible impacts on smaller healthcare companies around the globe.