Tag Archives: FDA

Jim Edwards: FDA Has Only 2 Inspectors Watching Drug Factories in China

Jim Edwards reported Friday on BNet that the FDA has all of rwo inspectors in China. From FDA Has Only 2 Inspectors Watching Drug Factories in China.

But the fact that the FDA has just two people to cover a territory 3.7 million square miles in size raises questions about how often those factories and labs will be inspected to make sure the drugs they are producing are safe for Western — or indeed any — patients. An FDA spokesperson said in a statement to BNET:

We have two inspectors for medical products. I must emphasize that in addition to those two in-country inspectors, many U.S.-based FDA inspectors continue to make short-term trips to China to perform inspections.

BNET noted a year ago that Pfizer

alone — the world’s largest drug company — is expanding in China faster than the FDA can possibly visit its facilities. Pfizer’s goal (prior to the merger with Wyeth) was to be in 137 Chinese cities. At the time, the LA Times reported that the FDA had 12 people in China. Which would mean that to inspect Pfizer’s facilities the FDA would have to inspect one site every 2.7 days, and take no vacations or weekends. Here’s the FDA’s historic rate of Chinese inspection for all companies, from 2002-2007, according to the GAO:

The lowest rate of inspections in these 10 countries was in China, for which FDA inspected 80 of its estimated 714 establishments, or fewer than 14 establishments per year, on average.

We don’t know – but hope that Edwards follows up on –

  1. do these two work together or alone:
  2. do either speak Chinese?
  3. If so, what dialects?
  4. What integrity controls does the FDA have in place?By the same token, what personnel protection does the FDA have in place?

Some of Edwards’ other excellent reporting on these issues:

FDA Warning on Zicam cold remedy

, according to Gardiner Harris of the Times. Federal drug regulators warned consumers to stop using Zicam, a popular homeopathic cold remedy, because it could damage or destroy their sense of smell.

The action is an early indication that the Obama administration is likely to take far more aggressive enforcement actions against drug companies than the Bush administration did.

The Food and Drug Administration received 130 reports from consumers and doctors of people losing their sense of smell after using one of the Zicam nasal products, which include Zicam Cold Remedy and Zicam Cold Remedy Swabs. The reports date to 1999, when Matrixx Initiatives of Scottsdale, Ariz., first introduced the products. Continue reading →

FDA threatens Red Cross with criminal charges over blood supply

Stephanie Strom of the Times reports on persistent – over 15 years – difficulties with the Red Cross blood supply operation, which provides two-thirds of the organization’s revenue.

For 15 years, the American Red Cross has been under a federal court order to improve the way it collects and processes blood. Yet, despite $21 million in fines since 2003 and repeated promises to follow procedures intended to ensure the safety of the nation’s blood supply, it continues to fall short.

The situation has proved so frustrating that in January the commissioner of food and drugs attended a Red Cross board meeting – a first for a commissioner – and warned members that they could face criminal charges for their continued failure to bring about compliance, according to three Red Cross officials who attended the meeting and requested anonymity because Red Cross policy prohibits public discussion of its meetings with regulators.

If fear is a motivator, we’re happy to help out in that way,” said Eric M. Blumberg, deputy general counsel at the Food and Drug Administration, though he declined to confirm what the commissioner, Andrew C. von Eschenbach, said at the meeting.

Some critics, including former Red Cross executives, have even suggested breaking off the blood services operations from the rest of the organization, as the Canadian Red Cross did a decade ago.

The problems, described in more than a dozen publicly available F.D.A. reports – some of which cite hundreds of lapses – include shortcomings in screening donors for possible exposure to diseases; failures to spend enough time swabbing arms before inserting needles; failures to test for syphilis; and failures to discard deficient blood.

In some cases, the lapses have put the recipients of blood at risk for diseases like hepatitis, malaria and syphilis. But according to the food and drug agency, the Red Cross has repeatedly failed to investigate the results of its mistakes, meaning there is no reliable record of whether recipients were harmed by the blood it collected.

The Red Cross, which controls 43 percent of the nation’s blood supply, agrees that it has had quality-control problems and is working to fix them. Both its officials and the drug agency point out that none of the identified problems involve the most serious category of infractions. For instance, the Red Cross does a good job of testing for H.I.V. and hepatitis B, officials on all sides agree. And in general, Red Cross blood is regarded as some of the safest in the world.

Still, the drug agency says, the problems that remain in screening donors and following protocols for collection add unnecessary risk to blood transfusions, almost five million of which were done in 2007, according to the National Heart, Lung and Blood Institute.

“This is a critical piece of the public health infrastructure,” Mary A. Malarkey, director of the Office of Compliance and Biologics Quality at the drug agency, said in an interview. “I know it’s difficult to get so many people trained and properly supervised, but it has to be done.”

This week, the agency sent the Red Cross the results of yet another recent investigation that makes Ms. Malarkey’s point: From December 2006 to April 2008, the Red Cross distributed more than 200 blood products that it had already identified as problematic, according to the investigation report.

Fifteen years under court supervision without progress. Doesn’t this suggest some change in approach?

NYT: A Heart Device Is Found Vulnerable to Hacker Attacks

To the long list of objects vulnerable to attack by computer hackers, add the human heart.The threat seems largely theoretical. But a team of computer security researchers plans to report Wednesday that it had been able to gain wireless access to a combination heart defibrillator and pacemaker.

They were able to reprogram it to shut down and to deliver jolts of electricity that would potentially be fatal — if the device had been in a person. In this case, the researcher were hacking into a device in a laboratory.

Barnaby J. Feder , “A Heart Device Is Found Vulnerable to Hacker Attacks, The New York Times