Failure to act by the US Food and Drug Administration has increased the risk that criminals are operating in, and undermining, the drug regulatory process, Congress has been warned.

The agency has neither the will nor the authority to debar companies or individuals convicted of crimes such as bribery, fraud, perjury, blackmail or extortion, according to a report prepared for Representative Joe Barton, ranking (Republican) member of the House Committee on Energy and Commerce.
The Generic Drug Enforcement Act (GDEA), which was signed into law by President George W Bush in May 1992, gives the FDA debarment powers, but it only permits actions against generics firms, not brand-name drugmakers, and against felonies related to generic drug applications only.

Nevertheless, in the 15 years since GDEA passed into law, the FDA has not debarred a single generic drug company, even though some such firms have been convicted of criminal felonies that would have made them eligible for debarment, says the report, which was produced by the Committee’s minority staff.
Moreover, while the agency has debarred a total of 71 individuals since 1992, 32 of them were involved in the generic drug scandal of the late 1980s, and in the last five years the debarment rates has been just 2.5 per year, it adds.

However, the researchers have compiled a list, from FDA enforcement records for FY2003-FY2005, of 40 people convicted of crimes who, they say, could and should have been debarred. “In some instances, there was reason to believe from available evidence that these convicted criminals who should have been debarred continued to be involved in the drug industry,” they warn. There have been no debarments since January 30, 2007, over a year ago, the research also reveals.

The report has grown out of the ongoing investigation by the House Committee’s oversight and investigations subcommittee into the FDA’s review and approval of the New Drug Application (NDA) for Sanofi-Aventis’ antibiotic Ketek (telithromycin), which was submitted on February 28, 2000, and specifically, whether Sanofi deliberately submitted inaccurate clinical trial data for Ketek to the FDA. The panel discovered that, although Anne Kirkman-Campbell, a clinical investigator in a Ketek safety trial, had been convicted of a felony under federal law due to her misconduct in the trial, the FDA did not move to debar her until almost three years after she had been sent to jail.

The report also notes that some debarment actions have been initiated outside the five-year deadline mandated by GDEA, so they have had to be rescinded. Since January 1, 2000, FDA has taken over 38 months on average just to start the debarment process, yet another agency, the Federal Communications Commission (FCC), took only about eight months to debar individuals completely. The FDA has also failed to initiate proceedings in a consistent manner, and to debar individuals convicted of crimes relating to misconduct before other federal agencies, said the researchers.

The researchers remind Congress that it granted the FDA debarment authority in order to restore or maintain consumer confidence and protect the integrity of the regulatory process “by excluding bad actors from the drug industry,” and they believe the agency’s poor performance is due to it being hampered in two ways. First, it lacks adequate authority; it cannot debar companies other than those that submit generic drug applications and it cannot act against companies for post-approval criminal conduct. Second, FDA lacks focus in its debarment actions and its application of this authority has been “uneven,” with “unacceptable” delays in starting the process.

“It is doubtful that this is simply a matter of resources; as the debarment record of the FCC shows, other agencies have been able to start and complete debarments promptly. Instead, the GDEA’s five-year window to start the debarment process may be giving the FDA the perverse incentive not to move quickly on debarments,” the researchers suggest.

They urge Congress to extend the GDEA’s debarment provisions to companies producing brand-name drugs, biologics, animal medicines and medical devices. They also believe that Congress should consider whether misconduct occurring after a drug’s approval should be a basis for debarment and make changes in the statute that would incentivise the FDA to start and complete debarments more quickly and efficiently.

“More than 15 years ago, Congress passed a law to let the FDA kick out companies and individuals from the drug industry convicted of crimes related to the FDA approval process. This staff report shows in great detail the record of weaknesses in FDA’s ability and authority to carry out its duties and to protect its own integrity,” said Rep Barton. “When it comes to excluding the worst of the worst - convicted felons - FDA’s debarment process seems to be nonexistent,” he went on, adding: “it is inexcusable that the FDA can’t quickly debar convicted felons.” Rep Barton now says he will introduce legislation to reduce the agency’s budget when it fails to enforce the law.