Is An FDA Crackdown Coming?

Over the last 18 months, calls for tougher enforcement of drug manufacturers and increasing site inspections of drug manufacturing facilities have been coming from public advocacy groups and now from the U.S. Congress. This article looks at the pressure on the FDA to step up enforcement, and the potential impact on the medical gases industry.

Starting with the highly publicized failure of FDA to take decisive enforcement actions in securing the flu vaccine supply, Congress has been investigating the FDA enforcement record. The initiating event occurred when British regulators were forced to close the Chiron Corporation vaccine production facility in Liverpool, UK, due to widespread safety violations. A subsequent investigation by the House of Representatives Committee on Government Reform determined that FDA field investigators had uncovered and documented serious violations at Chiron in June 2003. Field investigators had recommended that FDA initiate an enforcement action against the firm. Their recommendation, however, was rejected, and the FDA was caught by surprise when British authorities subsequently closed the plant in October 2004. The United States had to ration flu vaccines that year as a result.

In the spring of 2005, the House Government Reform Committee initiated an investigation of the FDA enforcement record under the Bush Administration, with specific focus and attention on cases where career investigators believed official action to protect the public health was warranted, but where no action was taken by FDA. In June 2006, Representative Henry A. Waxman’s office released the report Prescription for Harm—The Decline in FDA Enforcement Activity. (This report can be viewed from the GAWDA medical gases consultant page at www.gawda.org.)

The report examined FDA documents requested by the committee from 2001 to present, which revealed that FDA enforcement activity declined over 50 percent from calendar year 2000 to calendar year 2005. Documents provided by the FDA show that enforcement actions in 2005 reached a 15-year low in enforcement activities. The report makes the point that the reduction in enforcement actions does not appear to be coming from increased compliance by manufacturers. The data reviewed by the special investigative division found that 483s issued between the years 2000 and 2005 range between 6,344 and 7,813, and that in many years the number of 483s issued by inspectors went up, while enforcement actions declined by double-digit percentage rates. The report states that headquarters officials have routinely rejected the enforcement recommendations of career field inspectors.

A key factor cited in the report as being a dampening effect on enforcement was the new enforcement policy announced in 2001 by the Director of the Office of Enforcement. This policy eliminated the authority of FDA district offices to issue warning letters, or take other enforcement actions, and required all such actions to be approved by FDA headquarters.

The release of this report just four short months ahead of congressional mid-term elections is no accident. Clearly Democrats intend to make the FDA’s enforcement record under the Bush administration a political issue for the fall elections.

Enforcement activity in the pharmaceutical industry has always resembled somewhat of a pendulum, swinging between stronger and weaker enforcement. In our opinion, the pendulum is about as far to the lenient side as it is likely to ever get, and pharmaceutical companies, including medical gas firms, must expect to see more and stronger enforcement actions in the coming years. In any event, congressional pressure such as the Waxman report is bound to have an influence on FDA senior officials and the Bush administration, forcing them to step up enforcement. If, for instance, FDA were to once again modify its enforcement policy, restoring authority to the district offices to initiate enforcement actions, this seemingly small step would have a potentially significant and immediate impact on the pharmaceutical industry, including gases.

Our advice is to get your house in order now, and not to wait for this increased enforcement activity to manifest itself. Conducting a mock FDA audit of your medical gas operations is a good way to assess any compliance gaps and develop a plan to fix any compliance problems.

Gases and Welding Distributors Association
Meet the Author
GAWDA Medical Gases Consultant J. Robert Yeoman is president & CEO of B&R Compliance Associates LLC in Lehigh Valley, Pennsylvania. Members can reach him at (610) 868-7183 and at bob.yeoman@brcompliance.com.