Mike Leavitt

Leavitt: We'll bar subs-par exporters

Fri, 16 May 2008 06:59:56 -0400

U.S. Health and Human Services honcho Mike Leavitt is baring his teeth at Chinese exporters that don't meet certification standards. Saying that regulators simply can't inspect all imported goods--some $2 trillion this year--companies that don't meet FDA standards won't be allowed to sell their products in the United States.

Leavitt's comments came during a trip to China to follow up on an agreement reached with Chinese regulators in December. Then, officials agreed to boost certification and regulation of exporters and to close some loopholes that have allowed Chinese companies to ship off unsafe food and drugs. Exporters are now required to register with the Chinese government, which will certify that they meet FDA standards.

Among the loopholes left to close: One that allowed chemical companies to produce drug ingredients without being inspected by drug regulators. That, of course, is one of the reasons why heparin tainted with oversulfated chondroitin made its way from Chinese suppliers to the U.S., where it was eventually recalled--but only after being linked to hundreds of severe allergic reactions, including up to 81 deaths.

- see the story in the Wall Street Journal

Leavitt: We'll bar subs-par exporters

Fri, 16 May 2008 06:59:56 -0400

- see the story in the Wall Street Journal

Politics hampers heparin probes

Mon, 12 May 2008 06:59:57 -0400

On the one hand, we have Health and Human Services Secretary Mike Leavitt gladhanding Chinese officials as he announced the heparin supply is now safe--including the crude heparin coming from China's workshops. On the other, there's Rep. Bart Stupak (photo), whose congressional committee is investigating the heparin debacle, contending that, "The FDA thinks they have it under control, but they really don't. If I was the FDA director, I'd shut down every drug coming in from China" until they were deemed safe, he told the Wall Street Journal.

Stupak is riled because the FDA won't hand over the names of Chinese heparin suppliers, citing confidentiality agreements. He and his committee worry that Chinese companies aren't fully cooperating with the agency's probe; during recent testimony, an FDA inspector said Chinese manufacturers didn't give them complete access to suppliers of crude heparin. Of course, Chinese officials accused Baxter of stonewalling their investigation, too.

All of which shows that politics is clouding the process of tracing contaminated heparin back to its source or sources--politics that go way beyond the typical Democrats-versus-Republicans grandstanding in our nation's capitol. Because this investigation crosses international boundaries, inspectors are hamstrung by deals higher-ups made on their behalf. As the top brass are smiling and making promises, the on-the-ground investigators are fighting red tape. Yet another unforeseen consequence of the globalization of pharma.

- read the article in the Wall Street Journal
- see Leavitt's pronouncement
- check out the UPI story

ALSO: The FDA sent out a new round of alerts to hospitals, pharma groups, and medical societies after learning that some medical facilities still had contaminated heparin among their supplies. Report

FDA's China office opens next month

Tue, 15 Apr 2008 06:59:56 -0400

FDA watchdogs will move into China next month, HHS Secretary Mike Leavitt said. The agency's Chinese office signals a new approach toward food and drug safety, he said; it's too tough to try to catch unsafe products at the U.S. border. "[W]e're changing our strategy... to building safety into the products," he said.

Heading up the China office will be Christopher Hickey, currently director of HHS' Asia and Pacific office. Though FDA staff will start working there next month, the office won't officially be open till October. According to previous reports, the agency plans to establish eight FDA positions at U.S. diplomatic posts in China and to hire five Chinese employees in key cities.

The new office, of course, is a response to a string of contaminated products coming out of China. Most recently, tainted heparin whose active ingredient was made in China forced a massive recall; the drug has been linked to 62 deaths and hundreds of allergic reactions. The new office also affirms the current realities of the drug industry: About 40 percent of drugs and 80 percent of their ingredients are imported, a growing number from countries such as China and India, where drug-safety controls are new. Leavitt said the U.S. plans to build a presence in other countries besides China, such as India and Central America.

- read the Associated Press story
- see the article in the Wall Street Journal

Related Articles:
FDA moves to allay drug-import fears. FDA report
Americans distrust drugs from China, India. Drug report
FDA wants satellite offices overseas. FDA report
Overseas drugmaking goes unsupervised. FDA report

Republicans scold Leavitt for stonewalling

Fri, 29 Feb 2008 06:59:55 -0500

When HHS Secretary Mike Leavitt first refused to give a Congressional committee some requested documents, the Democrats on that committee raised Cain. Now, the Republicans are hopping mad, too. They wrote Leavitt last night, threatening to hold him in contempt for refusing to hand over the info.

At issue is a briefing document that discussed Ketek, the antibiotic whose initial FDA approval is under investigation. "[T]he types of records requested by the subpoena have been provided for years by both Democrat and Republican secretaries," the lawmakers wrote. They also dissed Leavitt's claim of a "chilling effect" should he give up the documents, saying that courts haven't recognized that as an excuse for violating a subpoena.

For his part, Leavitt says he'll negotiate a compromise, perhaps by making FDA staffers available for interviews instead. We'll keep you posted.

- read the item at Pharmalot

Related Articles.
FDA official: Ketek data obviously fake. Report
FDA criticizes Aventis for Ketek study failures. Report
Senator makes dramatic demand in Ketek probe. Report