In a speech to the Food and Drug Law Institute Dr. Margaret Hamburg, the new FDA Commissioner, outlined a six step program to increase enforcement of FDA regulations. Stating that there had been a steep decline in enforcement actions, coupled with unreasonable delays in following through on serious public health problems, Hamburg stated in unequivocal terms that things were changing immediately to increase consumer protections and change the direction of FDA.
A review of recent FDA Warning Letters shows that there has indeed been an increase in enforcement and that there is a new emphasis on enforcement actions and a change in the climate at FDA from the previous administration. My hunch is that food good manufacturing practice (GMP) inspections will lead the way in receiving FDA attention with other GMP programs not far behind. However, when there is a change in the FDA enforcement climate it impacts all inspectional programs. Dr. Hamburg also signaled an increased scrutiny of internet health fraud. She emphasized the need to follow-up when FDA has found serious problems.
“In some cases, serious violations have gone unaddressed for far too long,” Hamburg said. “These include violations involving product quality, adulteration, and misbranding; false, misleading, or otherwise unlawful labeling; and misleading advertising,” Hamburg stated. The entire address is available on the FDA homepage at http://www.fda.gov
Here is an outline of Dr. Hamburg’s six step program which is excerpted from the FDA website, with my comments in parenteses:
“First, the FDA will set post-inspection deadlines (for violative inspections).
Second, the FDA will take responsible steps to speed the issuance of warning letters (the exact opposite of 2001).
Third, the FDA will seek to work more closely with our regulatory partners (local, state, and international regulatory agencies) to develop effective risk control and enforcement strategies. (FDA has long worked closely with the states but has a poor history of international cooperation)
Fourth, the FDA will prioritize enforcement follow-up. After a warning letter is issued or a major product recall occurs, we will make it a priority to follow up promptly with appropriate action.
Fifth, the FDA will be prepared to act swiftly and aggressively to protect the public. The FDA will no longer issue multiple warning letters to noncompliant firms before taking enforcement action (this is a dramatic change from current practice).
A sixth new practice is a little different from the others. It relates to our response to firms after they have made necessary corrections.
At my direction, the FDA is developing a formal warning letter “close-out” process. If the FDA can determine, usually based on a re-inspection, that a firm has fully corrected the violations raised in a warning letter, we will provide to the firm a “close-out” letter, indicating that the issues in the warning letter have been successfully addressed. To keep the public informed, we will indicate on our website when a firm has received a “close-out” letter.” (lose out letters for warning letters is something very new. It might help give a warning letter more clout and ce rtainly gives industry a motivation to clean up their act.)
CThen Dr. Hamburg gave two examples of FDA’s new enforcement posture. The quick action issuing Warning Letters to internet websites selling fraudulent products for the H1N1 influenza virus (swine flu) and a crackdown on “nutritional supplements” that contained illegal anabolic steroids.
Now here are my two complaints regarding Dr. Hamburg’s speech. While cracking down on the sales of clearly fraudulent products is commendable and something FDA has not done effectively for years, it is not a bold initiative. In fact, it is picking the low hanging fruit. These are easy enforcement actions to obtain because the violations are so blatant. Large food companies and big pharma seem to be left out of this push towards tougher enforcement standards. Or maybe I am being impatient.
Second, during the question and answer period, a food and drug attorney asked Dr. Hamburg about the lack of regulations for an increasingly complex regulated industry. She side-stepped the question and instead spoke of greater government transparency. That is too bad. FDA’s clinical trial regulations were written 35 years ago for a very different clinical trial industry. There are no regulations or enforcement for the huge clinical trial services industry including clinical laboratories and site management organizations. Computerized systems and part 11 compliance is something FDA rarely discusses. Combination products don’t have the level of regulatory oversight they need. There are a lot of areas that FDA needs to modernize and address.
Still, Dr. Hamburg only has been in office for eight weeks. She is certainly setting a different tone than in the past eight years. She mentioned Congressional support and increased funding for inspections and enforcement. This sounds like large steps in the right direction.