FDA criticized for accepting free help from company that later won generic OK

Introduction

The Food and Drug Administration last month issued guidelines for agency staff to follow when drugmakers offer free help during emergencies such as the 2008 heparin contamination crisis, the Government Accountability Office said in a new report.

Heparin is a blood thinning drug used by millions of patients, especially before surgeries and dialysis, and for treating blood-clotting conditions.

In early 2008, some patients using heparin made by Baxter Health Care Corp. died or had severe allergic reactions, which the FDA eventually traced back to contamination at Chinese heparin processing farms. Because of the emergency, the FDA said it accepted free help from scientists, some of whom had financial ties to heparin manufacturing companies.

“FDA officials were aware of scientists’ ties to heparin manufacturers but did not take adequate steps to consider whether these relationships exposed the agency to the risks,” the GAO report said. The watchdog warned that accepting help from the scientists could compromise public confidence in the FDA and recommended the agency create a policy for accepting outside help during emergencies. The FDA issued such guidelines on Oct. 15, the GAO said.

One of the FDA’s free consultants was Momenta Pharmaceuticals Inc., a company that later won permission from the agency for the first rights to sell a generic version of the fast-acting bloodthinner Lovenox, according to The Wall Street Journal. The FDA says Momenta’s free work did not influence the agency’s decision.

The GAO report, which does not mention Momenta Pharmaceuticals, was requested by Rep. Joe Barton of Texas, the senior Republican on the House Energy and Commerce Committee. Barton has criticized the FDA for allowing imports of heparin from Chinese plants that refused to allow full inspections.

FAST FACT: More than half of the finished heparin products in the U.S. and globally are made from Chinese-sourced materials.

Following are other new watchdog reports released by the Government Accountability Office (GAO), various federal Offices of Inspector General (OIG), and other government entities:

ENVIRONMENT

• Appliances with an Energy Star label rely on manufacturers self-certifying the amount of energy or greenhouse gas emissions savings, and do not reflect any federal tests to verify the savings. (OIG)

FINANCE

• Annual audit shows the Treasury Department’s Bureau of Public Debt has maintained effective internal controls as government debt rose by 60 percent to $13.6 trillion in 2010 from $8.5 trillion in 2006. (GAO)