FDA: Give Authority To Improve Prescription Drug Safety
Officials of the U.S. Food and Drug Administration (FDA) say Congress must provide them with more resources and authorities to ensure the safety of imported prescription drugs. A congressional hearing Tuesday included dramatic testimony by family members of people whose deaths are thought to have been caused by contaminated doses of the medication Heparin.
Tearful statements during the day-long hearing were a powerful reminder of the human loss from shortcomings in U.S. inspection capabilities of prescription drugs, and what companies say was apparent deliberate contamination of batches of Heparin originating in China.
Family members spoke about the deaths of loved ones apparently from allergic reactions to Heparin.
In the space of a few weeks, Leroy Hubley lost his wife Bonnie and son Randy, both of whom were treated with Heparin recalled by the U.S.-based company Baxter International, while Johanna Marie Staples lost her husband.
"On December 19th, 2007 the doctors recommended removing her feeding tube[s], to end her suffering," Hubley said.
"This drug certainly increased Baxter's corporate bottom line," Staples said. "Baxter delivered larger dividends to stockholders according their 2007 annual report, board members received additional benefits while failing to recall a bad drug, a drug that was already known to have serious adverse effects."
Used to prevent blood clots, and important for kidney dialysis, Heparin comes from pig intestines, with increasing amounts of processing taking place in China.
Robert Parkinson, CEO of Baxter International, expressed regret, says the company believes the contaminant known as over-sulfated chondroitin sulfate was added to Heparin deliberately.
"We are alarmed that one of our products was used in what appears to have been a deliberate scheme to adulterate a life-saving medication and that people have suffered as a result," he said.
David Strunce represents Scientific Protein Laboratories (SPL), Baxter's supplier. He says contaminants were present in crude or raw Heparin before they reached the company's plant in Changzou, China.
"The recent worldwide contamination appears to be the result of a deliberate act upstream in the supply chain," he said. "The contaminant was not SPL or Changzou SPL specific. The contaminant has now been detected in Heparin products by a wide variety of manufacturers around the world with no connection whatsoever to our suppliers."
FDA officials have pointed to the inability of the under-funded agency to keep up with the sharp increase in foreign-originated drugs.
In the words of Janet Woodcock, with the agency's Center for Drug Evaluation and Research, an agency of the 20th century is not configured to regulate a 21st century globalized pharmaceutical industry.
"Generic drug applications processed in 2007 at the FDA referenced over 1,000 foreign sites," she said. "450 of those were in India, 497 of those were in China, and only 151 of them were in the United States."
U.S. authorities attribute 81 deaths in the United States to contaminated heparin, and the FDA says it identified 12 Chinese sources of contaminated heparin going to 11 foreign countries.
Officials say all major Chinese suppliers, agreed to voluntary tests to confirm drug purity, but they acknowledge that only one Chinese company was placed under what is called an import alert."Someone did this deliberately," he said. "They found a product, much cheaper than the active ingredient, so they could hide it under [normal] testing and no one would be the wiser until people dropped dead and [by] which time [they] have made a lot of money and [they] were off to doing other things."
Congressman John Dingell is the chief sponsor of pending legislation to increase funding for the the Food and Drug Administration so its inspections of foreign drug factories approach or meet standards for inspections of companies in the U.S.
"You cannot tell me that you are able to do that in China. You don't have enough people, you don't investigate them often enough," he said. "You haven't been able to stop the importers from bringing this in without the agreements that they are going to provide the necessary inspections in China. American manufacturers have to engage in manufacturing using good manufacturing practices. Chinese don't. How does this situation protect the American public?"
Sharply increasing inspections of foreign drug processing plants would, FDA officials say, require between $200 million and $300 million. The agency has faced criticism from lawmakers who say it has not requested adequate funding.
While most of the focus has been on heparin from Baxter International, the FDA continues to investigate deaths of other patients and other companies could face legal action.
Last week, a lawsuit was filed in a Boston court against the Massachusets-based health care company Covidien, Inc., with attorneys alleging that a Missouri man died after receiving contaminated Heparin.