[Ip-health] BNA: Republicans Ask for Hearing on Patent Reform Bill's International Impact

[Mike Palmedo]

http://pubs.bna.com/ip/bna/PLP.NSF/eh/a0b6e3k2a7

Michaud, Manzullo Urge Examination Of Patent Reform's International Impact

BNA Pharmaceutical Law & Industry Report
March 14, 2008

Republican lawmakers March 11 asked the Government Accountability Office
to examine questions surrounding the Food and Drug Administration's use
of disciplinary actions against clinical investigators.

Reps. Joe Barton (R-Texas), ranking member of the House Energy and
Commerce Committee, and John Shimkus (R-Ill.), ranking member of the
committee's Oversight and Investigations Subcommittee, asked GAO in a
letter to examine the reasons for delay with FDA initiating disciplinary
proceedings against clinical investigators who have engaged in misconduct.

They also asked GAO to determine whether FDA's biomedical research
monitoring program is effective in identifying clinical investigators
whose practices or conduct may compromise clinical data or the safety of
participants in clinical trials.

"FDA has waited months and sometimes years to take action against
doctors who lied about their work on critical clinical studies of new
drugs and who put their own patients at risk," Barton said. "There's
just no excuse for not invoking the authority FDA already has to rapidly
disqualify liars from taking any further role in these drug studies."

"GAO is Congress's watchdog and I want them to start digging into this
as soon as possible," added Barton. "We need to understand what's gone
haywire with the system and how FDA can quickly detect and remove the
clinical investigators who engage in misconduct during drug trials."

In February, the Republican staff released a report highlighting the
inadequacy of FDA's efforts on debarring clinical investigators from
future work on drug trials (6 PLIR 183, 2/15/08). The investigation was
spurred on by hearings on FDA's handling of an antibiotic called Ketek.

Anne Kirkman-Campbell, a clinical investigator in a Ketek safety trial,
had been convicted of a felony under federal law because of misconduct
during the approval process. FDA, however, did not move to debar her
until nearly three years after she had been incarcerated.

The report found that FDA lacks both full authority and the will to
remove from the process companies and individuals convicted of crimes
related to the drug approval process, the Republicans said.
Consequently, these companies and individuals can continue to help move
medical device and drug applications through the approval process.
Crimes resulting in debarment can include bribery, fraud, perjury,
making false statements, blackmail or extortion.

"How can the American public trust FDA-regulated clinical tests if those
conducting the tests are not reliable? The FDA needs to act quickly to
remove those involved in misconduct so that test results are not
compromised," Shimkus said.

The letter is available at
http://republicans.energycommerce.house.gov/Media/File/News/031108_FDA_Disqualification_Letter.pdf
on the Web.


--
Mike Palmedo
Research Coordinator
Program on Information Justice and Intellectual Property
American University, Washington College of Law
4910 Massachutsetts Ave., NW Washington, DC 20016
T - 202-274-4442 | F 202-274-0659
mpalmedo@wcl.american.edu