Congressman Questions FDA's Heparin Investigation - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Congressman Questions FDA's Heparin Investigation


ePT--the Electronic Newsletter of Pharmaceutical Technology

Washington, DC (Nov. 24)—In a letter to Acting Comptroller General Gene Dodaro dated Nov. 19, 2008, Congressman Joe Barton (R-TX) requested that the US Government Accountability Office (GAO) review the US Food and Drug Administration’s handling of the highly publicized tainted-heparin scare that occurred in 2007 and 2008. Congressman Barton is a ranking member of the US House of Representatives Committee on Energy and Commerce.

Concerns raised by Barton include whether FDA thoroughly investigated the heparin situation and whether the agency has been completely forthcoming with its findings. Barton cites potential discrepancies in information provided by FDA in regards to three reported patient deaths. Barton suggests in the letter to GAO that statements made in the press by FDA that heparin was linked to the deaths of three patients potentially contradict information provided by FDA to Barton. “FDA classified the cause of death from heparin as only ‘possible’ in two of those cases, and ‘unassessable’ in the third case,” Barton states. According to Barton’s letter, Baxter Healthcare Corporation (Deerfield, IL), the manufacturer of the heparin in question, performed its own investigation into the deaths and concluded that the three deaths were unlikely to be a result of heparin use.

Also in question is FDA’s potential lack of follow-up investigations, including interviewing clinical staff and the failure to use medical reporting databases other than the FDA’s Adverse Events Reporting System. In the Nov. 19 letter, Barton states his concern that FDA may not have thoroughly investigated reported deaths because the agency “did not follow up to interview clinical staff or Baxter for further details about each of these cases. In addition, FDA told Minority Committee staff the agency did not access other [adverse drug reaction] databases…” 

The letter states that Barton believes FDA may not have made certain information regarding the investigation public and that conflicting information makes it unclear if heparin made by American Pharmaceutical Partners (APP, Schaumburg, IL) is safe. “Out of the 16 allergic reaction heparin death reports received by FDA with lot numbers, the only case in which FDA determined that the cause of death from heparin infusion was ‘probable’ involved a heparin drug made by American Pharmaceutical Partners,” Barton states.

The congressman expresses his concern that the heparin situation may indicate that FDA has not improved its drug safety system as it promised to do in 2007 hearings before the Subcommittee on Health and the Subcommittee on Oversight and Investigations. “The apparent gaps in FDA assessment and public communication about the cause(s) of heparin deaths raise questions about whether these FDA changes have actually resulted in real improvement in drug safety oversight,” states Barton in his letter to GAO. Barton hopes “GAO’s review will determine the strengths and weaknesses in FDA’s response to the heparin drug safety problem, and will make recommendations on what FDA could do better in dealing real-time with an emerging drug safety problem in the future.”

Early in 2008, FDA investigated reported adverse drug affects associated with the use of the blood thinner heparin. In March 2008, FDA found the contaminant over-sulfated chondroitin sulfate in the active pharmaceutical ingredient produced by a Chinese manufacturer for Baxter.

For additional information on the heparin contamination, visit:

FDA’s drug advisory

The Feb. 14, 2008 ePT story, Baxter Voluntarily Recalls Heparin Lots

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here