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:

• AstraZeneca Moves Drug Production to China, Begging Safety Questions for FDA
• The closing of Pfizer facilities in New London, Connecticut;
• Pfizer Aiming for 30,900 Layoffs Through 2012
• Edwards’ excellent coverage of Merck Layoffs

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.

In 2006, Matrixx paid $12 million to settle 340 lawsuits from Zicam users who claimed that the product destroyed their sense of smell, a condition known as anosmia. Hundreds more such suits have since been filed.

Although the F.D.A. took no action during the Bush administration, Dr. Margaret A. Hamburg, who was named the agency commissioner by President Obama, said the incidence of anosmia associated with Zicam “strikes us as a fairly large problem.”

The agency issued its consumer alert even though Matrixx refused to recall its products, a highly unusual event. In a news release, Matrixx said it had suspended shipments of Zicam and would reimburse customers who wanted a refund.

“Matrixx Initiatives stands behind the science of its products and its belief that there is no causal link between its intranasal gel products and anosmia,” the release said. “For this reason, Matrixx Initiatives believes that the F.D.A. action is unwarranted and will seek a meeting with the F.D.A. to review the company’s product safety data.”

Matrixx had $101 million in sales last year, of which $40 million came from Zicam products. Because Matrixx has called Zicam a homeopathic product, the company was not required to seek agency approval before selling it.

The F.D.A. does not have the power to order product recalls but must rely on manufacturers to do so voluntarily. Bills now moving through Congress would give the agency that power. Bush administration appointees said the F.D.A. did not need mandatory recall authority because companies always withdrew unsafe products when asked.

But the government sometimes negotiated for days or weeks before companies agreed to recalls, leading many more consumers to be put at risk. And the Zicam case demonstrates that aggressive enforcement action can lead to disagreements.

An F.D.A. warning letter sent to Matrixx on Tuesday states that Zicam Cold Remedy intranasal products “may pose a serious risk to consumers who use them” and are “misbranded.” Such language would normally describe a recall alert. The products have no proven benefits.

Matrixx has received more than 800 reports of Zicam users losing their sense of smell but did not provide those reports to the F.D.A., said Deborah M. Autor, director of compliance in the agency’s drug center. The law requires producers of approved drugs to forward to the F.D.A. all reports of product-related injuries, but Ms. Autor declined to say whether this reporting requirement applied to Matrixx.

“This disabling loss of one of the five senses may be long lasting or even permanent in some people,” Ms. Autor said. “People without the sense of smell may not be able to detect dangers such as gas leaks or smoke. They could lose much of the pleasure of eating, adversely impacting the quality of life.”

Dr. Charles E. Lee, a compliance officer in the agency’s drug center, said zinc could be toxic to nerve receptors in the nose. In the 1930s, intranasal zinc was tested as a polio preventative, and some patients suffered anosmia, Dr. Lee said.

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”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?

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