ParfumGigi@aol.com

2 mai 2008

The latest revelation in the heparin horror story is that the adulteration of the drug that resulted in at least 81 deaths in the U.S. may have been deliberate. What is known is that a substantial amount of a cheap chemical -- oversulfated chondroitin sulfate -- was substituted for heparin in some batches manufactured for Baxter International.

On Tuesday, members of Congress listened to the heart-wrenching stories of family members whose loved ones suffered and died due to the bad medicine. One man read his prepared testimony in a voice repeatedly strangled by sobs.

"Now I am left to deal not only with the pain of losing my wife and son," said Leroy Hubley, "but, anger that an unsafe drug was permitted to be sold in this country."

Unsurprisingly, the contamination has been traced to China -- and the FDA is now apparently passing the buck to Congress, saying it doesn't have the funds or the regulatory authority it needs to ensure the safety of imported drugs.

This is more than disconcerting. What we seem to have here is a federal agency throwing up its hands in frustration and protesting, "It's not our fault!"

According to VOA News, "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.'"

This is the same agency that insists that bringing drugs from a foreign country into the United States should remain illegal, because pharmaceuticals that aren't subject to its oversight might not be safe.

With the skyrocketing price of medications, many Americans -- particularly the elderly and others on fixed incomes -- have been turning to Canada, Mexico and other countries for cheaper prescription drugs. Despite the efforts of some legislators to come up with a regulatory framework that would make it both legal and safe to do so, the FDA has staunchly opposed any such measures.

According to an article on the FDA's own website, "Joe McCallion, a consumer safety officer in the FDA's Office of Regulatory Affairs, sums it up this way: 'If you buy drugs that come from outside the U.S., the FDA doesn't know what you're getting, which means safety can't be assured.'...

"As part of the FDA's high standards, drugs can only be manufactured at plants registered with the agency, whether those facilities are domestic or foreign," the article continues. "If a foreign firm is listed as a manufacturer or supplier of a drug's ingredient on a new drug application, the FDA generally travels to that site to inspect it.

"After the FDA approves a drug, manufacturers still are subject to FDA inspections and must continue to comply with good manufacturing practices. 'With an unapproved drug, you can't be sure that it has been shipped, handled, and stored under conditions that meet U.S. requirements,' McCallion says."

Federal law strictly limits "the types of drugs that may be sold within and imported into the United States and who may import them," reads a letter from the FDA to the mayor of Duluth, Minn., sent in February. "Congress enacted these provisions to create a relatively 'closed' drug distribution system, which helps ensure that the domestic drug supply is safe and effective."

On the one hand, FDA officials are sternly warning U.S. citizens against the perils of obtaining drugs outside the country. In response to the heparin catastrophe, though, they are admitting that many of the drugs subject to FDA regulation are processed outside of the U.S. at locations that it does not -- indeed, cannot -- inspect.

It strains credulity that the FDA is unaware of its own schizophrenia on the drug importation issue. What seems more likely is that the agency is in the pocket of the pharmaceutical lobby -- not an original notion, I realize. It's cost-effective for companies to outsource the manufacture of pharmaceuticals, so the FDA allows the practice and rubber-stamps the results.

Allowing retail pharmacies in other countries to compete with U.S. distributors could erode domestic profits, though -- never mind how diligent the governments of those countries might be in their safety monitoring -- so the FDA clamps down.

The bottom line seems to be that the FDA is preventing U.S. citizens from saving money by purchasing prescription drugs from other countries, while abdicating its responsibility for making sure that what's sold to us here at home is safe.

We need an FDA that has the resources, authority -- and cojones -- to stand up to the drug lobby and do the job it was established to do.

And to stop talking out of both sides of its mouth.