Report: FDA Taking Fewer Enforcement Actions

The number of actions taken by FDA to enforce drug and medical device safety -- such as warning letters and seizures of products -- declined from 2000 to 2005, according to a report requested by House Government Reform Committee ranking member Henry Waxman (D-Calif.), the New York Times reports. Waxman in 2004 began the inquiry after congressional hearings suggested that FDA was partly responsible for the 2004 shortage of flu vaccine.

According to the report, the number of warning letters issued to drug companies, medical device manufacturers and others by FDA declined from 1,154 in 2000 to 535 in 2005, a 54% decrease (Harris, New York Times, 6/27). Over that period, the number of violations reported by agency inspectors declined 1%, from 6,334 to 6,268 (Alonso-Zaldivar, Los Angeles Times, 6/27).

Because the number of violations remained steady, investigators concluded that the reduced number of FDA actions did not indicate that manufacturers were safer but that the reports were less likely to result in warning letters or other enforcement. FDA's Center for Devices and Radiological Health had the largest decline in warning letters, with 66% fewer letters issued in 2005 than in 2000.

FDA's Center for Drug Evaluation and Research had a 39% drop in warning letters (Kaufman, Washington Post, 6/27). Each of FDA's five centers issued fewer warning letters in 2005 than in 2000.

Waxman's inquiry also identifies 138 cases in which FDA officials did not take enforcement actions recommended by inspectors. Many of those cases involved medium- or small-sized companies selling over-the-counter treatments (Los Angeles Times, 6/27).

The seizure of defective, dangerous or mislabeled products fell 44%, according to the report (New York Times, 6/27). The report finds that the number of onsite inspections at manufacturing plants dropped nearly 50% from 2000 to 2005 (Washington Post, 6/27).

The only increase noted in the report is the number of recalled products, which rose 44% (New York Times, 6/27). The report says lack of enforcement exposes the public to "dangerous products" and creates an unfair "playing field for companies with strong safety records" (Cohen, Newark Star-Ledger, 6/27).

The report outlines specific cases in which FDA inspectors recommended actions that agency officials did not follow, including the following:

• A recommendation from the Denver office in 2001 that a warning letter be sent to a company whose hangover treatment had a toxic level of caffeine. Three people who took the treatment were sent to emergency departments. FDA officials said the issue did not meet the "regulatory significance threshold of enforcement."
  


• A recommendation that a warning letter be sent to a company whose anti-itch treatment contained no active ingredient. After 11 months, FDA rejected the recommendation, saying the company was a "very small operation" (Schmit, USA Today, 6/26).
  


• A recommendation that criminal proceedings be initiated against an Ohio medical supply company that sold a tank of nitrogen gas that was misidentified as oxygen. Four nursing home residents died as a result. FDA waited two and a half years before closing the case without taking action.
  


• A recommendation that a warning letter be sent to Purdue Pharma after the company failed within the mandatory time period to report 12 "serious and unexpected adverse events," including loss of consciousness and convulsions, caused by the epidural painkiller Chirocan. FDA rejected the call for a warning letter and instead sent a less severe letter.
  


• A recommendation that a warning letter be sent to a blood bank in Puerto Rico after field investigators found "significant and objectionable conditions" that resulted in one death and multiple patients receiving incorrect blood products. FDA took no action, saying the death was a "single, isolated event."

Waxman said, "Americans have relied on FDA to ensure the safety of their food and drugs for 100 years. But under the Bush administration, enforcement efforts have plummeted, and serious violations are ignored" (Newark Star-Ledger, 6/27). Waxman added, "The people who've been making decisions at the FDA have decided to favor industry."

Michael Wilkes, a professor at the University of California-Davis School of Medicine and former FDA enforcement official who reviewed documents at Waxman's request, said FDA "systematically ignores District Office recommendations" (USA Today, 6/26).

Sammie Young, a former FDA enforcement official who also reviewed the documents, said FDA officials frequently reject the "clear and thorough recommendations" of agency field offices. Young said FDA's actions are often "inadequate or unreasonable" (Newark Star-Ledger, 6/27).

David Elder, director of FDA's Office of Enforcement, in a statement said, "FDA enforcement cannot be properly judged by counting the number of actions taken by the agency. FDA has increasingly used an enforcement strategy based on efficient risk management principles that focus on combating the greatest public health risks and maximizing our deterrent effect against potential violators."

Elder noted that the agency has won legal actions taken against companies that violated the law, bringing in more than $2.5 billion since 2000 in fines, penalties and settlements (Washington Post, 6/27). Elder said the agency has been focusing more on the most serious violations that "present the highest risk to consumers and public health."

Elder also said the agency "has taken prompt, targeted and aggressive action against firms that are in violation of law" (New York Times, 6/27).

Alan Goldhammer, associate vice president of the Pharmaceutical Research and Manufacturers of America, said he did not "see anything in the report that indicates a reason for patients to be concerned about the safety and effectiveness of the drugs they receive."

AdvaMed, an association of medical device manufacturers, in a statement said, "FDA vigorously enforces the law," adding that fewer warning letters "could indicate better compliance on the part of manufacturers" (Newark Star-Ledger, 6/27).

NPR's "Morning Edition" on Tuesday reported on the report. The segment includes comments from Jerry Avorn, professor of medicine at Harvard Medical School and chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital; Michael McGarry, executive vice president for public affairs at AdvaMed; and Waxman (Silberner, "Morning Edition," NPR, 6/27).

The complete segment is available online in RealPlayer.