FDA may have mishandled the Heparin scandal
Questions are being raised as to the adequacy of the Food and Drug Administration’s handling of the contaminated blood thinner Heparin earlier this year. It is thought that the FDA misreported deaths tied to the product and didn’t thoroughly investigate the problem. It appears that the FDA released conflicting statements to the public and Congress about the number of deaths tied to contaminated Heparin.
The FDA said it linked three deaths to the defective drug in May, but last month claimed that only two of the deaths were possibly linked to Heparin when reporting to congressional staff.
Baxter International Inc., a company involved in the scandal, did its own investigation of the deaths and concluded that Heparin was not the likely cause in the three cases. Their investigation included obtaining medical records from patients, visiting a hospital where one of the patients had gone before dying, and interviewing pharmacists and nurses.
The FDA didn’t follow up with a clinical staff at the hospitals, talk with Baxter to find out further information about deaths, or access other medical databases it uses to evaluate drug safety problems.