WASHINGTON – U.S. Rep. Joe Barton of Texas, ranking Republican of the House Energy and Commerce Committee, along with 10 co-sponsors, today introduced the H.R. 6378, the Strengthening of FDA Integrity Act. The bill gives the Food and Drug Administration more authority to take action against companies that have been convicted of crimes relating to drug products.
“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,” Barton said. “Our staff report released in February showed in great detail the record of weaknesses in FDA’s ability and authority to carry out its duties and to protect its own integrity. When it comes to excluding the worst of the worst – convicted felons – FDA’s debarment process seems to be non-existent. It is inexcusable that the FDA can’t quickly debar convicted felons.
“But the report also showed that current law gives FDA no power to debar certain companies despite being convicted of crimes related to drugs,” Barton added. “This bill fixes the problem by giving FDA the authority it currently lacks.”
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.
A copy of the bill can be found here.
A copy of the Republican report on FDA debarment can be found here.
Co-sponsors of the bill are U.S. Reps. Nathan Deal, R-Ga., Ed Whitfield, R-Ky., John Shimkus, R-Ill., Heather Wilson, R-N.M., Chip Pickering, R-Miss., Mary Bono-Mack, R-Calif., Greg Walden, R-Ore., Lee Terry, R-Neb., John Sullivan, R-Okla., and Marsha Blackburn, R-Tenn.
