Food and drug companies that commit safety violations will face faster and more aggressive action, the new commissioner of the U.S. Food and Drug Administration promised last week.

The new chief of the United States Food and Drug Administration (FDA) promised last week to crack down on food and drug companies that break the law

In a speech sponsored by the Food and Drug Law Institute on Thursday, Dr. Margaret Hamburg talked about setting clearer standards for companies and faster timetables for action that the public may even be able to keep tabs on. Hamburg, confirmed as the head of the FDA in May, mapped out the agency’s role as enforcer last week.

“Again and again, from all sides of various questions, I heard support for a strong FDA…an agency that protects the safety of the food supply…an agency that facilitates access to safe and effective medical products…an agency for the American public to count on,” Commissioner Hamburg told a group of industry representatives, attorneys, consumers and others attending last week’s speech.

In recent years, the FDA has struggled to keep up with the growing responsibilities laid upon it by lawmakers, often without the necessary funds to carry them out. For these reasons and others, Hamburg said that some FDA enforcement actions over the past several years “have been hampered by unreasonable delays” and “in some cases, serious violations have gone unaddressed for far too long.”

The agency has been criticized in recent years for its handling of tainted peanut butter that “sickened hundreds, contaminated blood thinners imported from China linked to deaths, and an investigation into a salmonella outbreak that dragged on” until the material culprit was identified, the Associated Press reported.

It is no wonder consumers are skeptical about the safety of the food and medical products they buy. According to a study by the University of Minnesota’s Food Industry Center earlier this year, only 22.5 percent of consumers were confident that the food supply is safer now than in 2008. Earlier this year, the Centers for Disease Control and Prevention (CDC) announced that the safety of the United States food supply has not improved over the past three years.

“Companies must have a realistic expectation that if they are crossing the line, they will be caught, and that if they fail to act…we will,” Hamburg said in last week’s speech. “The agency must show industry and consumers that we are on the job.”

To that end, Hamburg highlighted six initial steps designed to hone the effectiveness and timeliness of the FDA’s regulatory enforcement system:

• Set post-inspection deadlines. The FDA will establish a clear time-line for regulated industry to respond to significant FDA inspection findings, generally giving no more than 15 days to respond to such findings before the agency issues a warning letter or takes other enforcement action.
• Take responsible steps to speed the warning letter process. The FDA will streamline the warning letter process by limiting review of warning letters by the Office of Chief Counsel to those that present significant legal issues.
• Work closer with FDA’s regulatory partners. In some cases, such as with food safety issues, state, local, and international officials can act more quickly than the FDA. When public health is at risk, the agency will coordinate with its regulatory partners to take rapid action.
• Prioritize follow-up on warning letters and other enforcement actions. The FDA will work quickly to assess and follow up on corrective action taken by an industry after a warning letter is issued or a major product recall occurs.
• Be prepared to take immediate action in response to public health risks. To better protect the public health, the agency is prepared to act more quickly and aggressively to deal with significant public health concerns and violations. Such actions may occur before a formal warning letter is issued.
• Develop and implement a formal warning letter “close-out” process. If the agency can determine that a firm has fully corrected violations raised in a warning letter, it will issue an official “close-out” notice and post this information on the FDA Web site. This will be an important motivator for corrective action by manufacturers.

By taking these steps, Hamburg said, the FDA will ensure that “violations are taken seriously, that warning letters and enforcement actions occur in a timely manner, and that steps are taken to protect consumers in cases where immediate enforcement action is not possible.”

Since Hamburg was confirmed as commissioner in May, the FDA has launched “a series of rapid-fire enforcement actions against companies selling bogus or dangerous products,” Matthew Perrone wrote in a separate Associated Press report. This type of enforcement will become routine in the future, according to Hamburg.

Earlier: Beefing Up Food Industry Regulations

Resources

Margaret Hamburg, M.D. on Effective Enforcement and Benefits to Public Health
U.S. Food and Drug Administration, Aug. 6, 2009

FDA Commissioner Sets Out Vision on Enforcement to Support Public Health
U.S. Food and Drug Administration, Aug. 6, 2009

FDA Vows Tougher Stance on Food, Drug Safety
The Associated Press, Aug. 6, 2009

Consumer Confidence in Food Safety Plunges in Wake of Peanut-Butter Contamination…
University of Minnesota’s Food Industry Center, Feb. 23, 2009

U.S. Food Safety No Longer Improving
by Gardiner Harris
The New York Times, April 9, 2009

FDA Chief’s Pledge Signals Tougher Safety Stance
by Matthew Perrone
The Associated Press, Aug. 6, 2009