Rep. Barton Introduces Legislation to Give FDA Greater Authority to Take Action Against Companies and Individuals Convicted of Crimes Involving Drugs and Devices

On June 26, 2008, ranking Republican of the U.S. House of Representatives Energy and Commerce Committee, Representative Joe Barton (R-TX), along with several co-sponsors, introduced the “Strengthening of FDA Integrity Act of 2008” (H.R. 6378).  According to an Energy and Commerce Committee Republicans press release, the bill:

• Gives FDA the authority to debar any company or individual who is convicted of crimes relating to any drug or device.

• Gives FDA the authority to debar companies for any misconduct relating to the drug or device, not just over misconduct that takes place during a drug or device’s development or approval.

• Provides great accountability by requiring the FDA to bring debarment actions within one year of the date of conviction.

• Requires the FDA to report to Congress on the number of debarment proceedings initiated and imposed each year.

H.R. 6378 follows a February 2008 report prepared for Rep. Barton by the Energy and Commerce Committee Minority Staff highlighting what is characterized as a “record of weaknesses in FDA’s ability and authority to carry out its duties and to protect its own integrity.”  According to Rep. Barton, H.R. 6378 “fixes the problem by giving FDA the authority it currently lacks.”

The Federal Food, Drug, and Cosmetic Act (“FDC Act”) was amended in 1992 by the Generic Drug Enforcement Act (“GDEA”).  Specifically, the GDEA, which was enacted in response to the discovery in 1989 of widespread corruption in the generic drug approval process, amended the FDC Act to authorize debarment and other penalties for illegal acts involving the approval of Abbreviated New Drug Applications.  According to the Energy and Commerce Committee Minority Staff report, however:

Since the passage of the [GDEA], FDA has not debarred a single corporation. After more than 15 years with the Act, FDA has debarred 71 individuals (five of the permanent debarments were later terminated and one was withdrawn), but almost half of these debarments (32) occurred in about the first 2 years of the Act and involved convicted felons who figured in the generic drug scandal of the late 1980s. . . .

FDA’s ad hoc approach to carrying out its debarment authority is partly to blame for its paltry enforcement record. At FDA, responsibility for handling debarments is not centralized; rather the manner in which it is handled is left to each FDA center. Although it was signed into law over 15 years ago, FDA has never issued regulations implementing the debarment provisions in the [GDEA].

The report notes that although “Congress granted debarment authority to FDA to serve a remedial purpose, ” the Agency’s ability to carry out this intent has been hampered in two ways:

First, FDA lacks adequate authority.  Under the statute, the agency cannot debar companies other than those that submit generic drug applications. The FDA also lacks authority to debar companies for post-approval criminal conduct. Second, FDA lacks focus in its debarment actions. A review of some cases involving debarred and non-debarred individuals convicted of FDA-related crimes demonstrates FDA’s uneven application of its debarment authority.

To address these issues, the report recommends that Congress consider, among other things, extending the GDEA’s debarment provisions to innovator drug and medical device companies, as well as whether a company’s misconduct post-approval should be a basis for debarment.  (Interestingly, during debate of GDEA legislation in 1990, the limitation to generic drugs was critized as too narrow by Rep. Henry Waxman and by Acting FDA Commissioner James Benson.)

H.R. 6378 incorporates many of the changes recommended in the report.  The bill was referred to the Energy and Commerce Committee for further consideration.  A companion bill has not yet been introduced in the U.S. Senate. 

By Kurt R. Karst 

ADDITIONAL READING: 

• John R. Fleder, The History, Provisions, and Implementation of the Generic Drug Enforcement Act of 1992, 49 Food & Drug LJ 89 (1994) – available here.