GAO: FDA Fails to Inspect Foreign Drug Plants Sufficiently

US General Accountability Office writes a scathing report on the FDA’s failure to inspect foreign drug manufacturing facilities.

Ed Silverman in Pharmalot blogs about the US General Accountability Office recent report which has determined that the FDA failed to implement earlier recommendations that would close the gap between the agency’s approach to inspecting domestic and foreign drug manufacturing facilities.

According to the Pharmalot post:

• The GAO writes that it is unclear if steps being taken by FDA “will prove successful” and there is an “urgent need” to better protect public health by putting GAO suggestions into practice.

• Here are some key findings:

o The FDA boosted its budget for foreign inspections to $41 million in fiscal 2009 compared with $12 million in fiscal 2008 and $10 million in fiscal 2007, and increased the number of foreign inspections.
o In fiscal year 2009, for instance, the FDA conducted 424 foreign inspections, compared to 333 and 324 inspections conducted in fiscal years 2007 and 2008, respectively.

• The GAO examined a list the agency kept to prioritize foreign inspections and estimated only 11 percent of the facilities were completed in fiscal year 2009.

• “At this rate, GAO estimated it would take FDA about 9 years to inspect all establishments on this list once.” That same year, 1,015 domestic inspections were made, or about 40 percent of domestic facilities.

• The FDA did not know how many foreign drug establishments were subject to inspection, because of inaccurate info in agency database. There were 3,765 facilities in the FDA databases, but 2,394 may never had been inspected. Most of these, not surprisingly, are located in China and India.

• The FDA continues to emphasize inspections of establishments listed on applications for a new drug, instead of those already producing drugs for US consumption. The FDA’s approach is “inconsistent” with the GAO’s 2008 recommendation that the FDA inspect plants, “at a comparable frequency,” that are identified as posing the greatest public health, regardless whether these are foreign or domestic, if there is a manufacturing problem.

• The US Department of Health and Human Services acknowledged the need for improvement, but cites obstacles toward progress, such as the need to obtain permission from the foreign government of the country in which an establishment is located in order to conduct an inspection.

Clearly this report is very troubling to the average health care consumer given the proliferation of raw material contamination's, recalls due to poor manufacturing process, adulteration, fraud and a myriad of other issues that plague our pharmaceutical supply chain.

Historically pharmaceutical companies are outsourcing more of their raw materials, production and packaging than ever before and the FDA does not have the capacity or ability to identify all of the manufacturing plants are that produce the drugs that are taken every day by US consumers.

Along with more robust inspections, it is incumbent upon all members of the supply chain to take measures to make absolutely certain that the products of their brand or the products they distribute or dispense are safe and efficacious.

Secure Pharma Chain encourages all members of the pharmaceutical supply chain to implement a variety of solutions and technologies to test and authenticate the products within their inventories to protect their brand and most importantly the consumer.

To read the entire Phamalot post, visit: http://www.pharmalot.com/2010/11/fda-fails-to-inspect-foreign-plants-sufficiently-gao/#more-27487

To learn more about pharmaceutical verification technologies, visit: http://www.xstreamsystems.net/.

Dallas Morning News: Investigation Reveals That Chinese Government "Hampered" FDA Probe of Tainted Heparin

In a follow up to a previous posting on a July 23rd posting of a Pharmalot.com blog, The Dallas Morning News in its Trail Blazers Blog continues the reporting on Congress questioning the FDA on their ability to work with the FDA on the Tainted Heparin probe.

According to the Dallas Morning News Trailblazer Blog:

"An investigation by Reps. Joe Barton and Michael Burgess has found that the Chinese government had 'severely hampered' a Food and Drug Administration probe into contaminated heparin." They wrote to FDA commissioner Dr. Margaret Hamburg, saying that "FDA officials informed them in June that the agency was 'denied full access to manufacturing and laboratory facilities,' nor were they allowed to review records." Notably, the "FDA investigation focuses on a batch of tainted heparin, a popular blood thinner that was linked to at least 81 deaths in 2007 and 2008."

The continued exposure of the lack of Chinese cooperation reveals to everyone within the pharmaceutical supply chain that there are many significant gaps in the ability of regulatory authorities to control and enforce the quality of medications that are now such a prevalent part of the pharmaceutical supply chain.

Secure Pharma Chain encourages industry supply chain leaders to take appropriate measures and deploy technologies that protect their brand, secure their inventories, differentiate themselves in the marketplace and most importantly save from harm consumers who take these medications.

To view the Dallas Morning News blog, visit: http://www.trailblazersblog.dallasnews.com/.

FDA Highlights Agency’s Plans for 2010

The FDA has some interesting plans for 2010. According to FDAnews here are a few highlights of the agency's plans:

• More than double the number of drug import field examinations
• 346 new hires for the signature Safer Medical Products initiative
• A 43 per cent increase in foreign GMP surveillance inspections
• New field offices in New Delhi, Beijing, Shanghai, Mexico, Costa Rica and other overseas hot-spots, manned by at least 60 staffers

Although XStream is supportive of increased enforcement and inspection, we encourage all commercial members of the pharmaceutical supply chain to increase their screening, verification and authentication of materials and products. Protecting your brand beyond regulatory enforcement is the key to success and avoidance of catastrophic failures within the supply chain.

Chinese Heparin Producers Get Warning Over Falsified Information

FDA issues letters to two more Chinese manufacturers regarding tainted Heparin

It reads like a bad sequel as more companies have been named in the tainted heparin scandal…

Two Chinese companies have been issued warnings from the FDA for falsifying information on Heparin. Shanghai No. 1 Biochemical & Pharmaceutical said they were manufacturing heparin, when in fact they were purchasing it from two outside companies. One supplier is no longer producing the medicinal product.

The other supplier, Qingdao Jiulong Biopharmaceuticals was also given a warning letter. Jiulong was found to have produced 19 lots of heparin contaminated with Over-Sulfated Chondroitin Sulfate (OSCS), a substance implicated in the U.S. deaths last year. The FDA further faulted them for not investigating how the substance got into the blood thinner and for exporting medicinal products without regulatory approval.

This warning letter was in response to the FDA’s inspection of Jiulong in August 2008. Jiulong told investigators that they did not ship directly to the United States. However, during inspections at U.S. facilities purchase orders were discovered indicating that the plant had been shipping heparin sodium to the U.S. since 2005. FDA also stated that in the past, the firm supplied heparin to Amphastar Pharmaceuticals Inc., a California company that supplies pre-filled syringes.

This story illustrates why analytical screening should be conducted throughout the supply chain – to ensure the quality of: those products supplied to your company, those products you supply to others, and ultimately the finished product consumed by the patient.

Will the FDA’s China Office Protect US Consumers?

The Washington Post, New York Times, Bloomberg News and a variety of other media outlets all have stories today announcing the Food and Drug Administration (FDA) deploying staff and opening its first office in Beijing, China.

This is the FDA’s reaction to China’s increasing role as a major exporter to the United States in food, drug and consumer products. Unfortunately China is also the world leader in exporting counterfeit, adulterated and contaminated products and the FDA is attempting to slow down the dangerous impact to US consumers. Recent high profile examples of counterfeit, adulterated and contaminated products include the recent heparin contamination which resulted in over 250 deaths in the US, the pet food contamination with melamine and the huge issue over lead paint on children’s toys. Most experts agree that these examples of toxic products within our consumer supply chain represent only a fraction of the dangerous products that are reaching our shores on a daily basis.

Apparently the FDA has plans this year to open up other offices throughout China and certify third-party inspectors who can approve and qualify the safety of exports to the United States.

The question is when will the FDA deploy a materials analysis technology that can look inside product packaging to inspect and protect the US consumer instead of throwing bodies at a high expense to attempt to catch the problem before it gets into our supply chain?

Stay tuned, we at XStream Systems are trying our best to introduce our revolutionary technology as a solution to catching the problem before it impacts our nations health.

XStream Systems Stories and News for the Week of October 24, 2008

Here are a few of stories that we at XStream Systems think are noteworthy as it relates to the ever growing issues of counterfeit and adulterated medications. XStream Systems thinks that its revolutionary technology that is capable of materials analysis of medications inside of sealed containers will be an important part of solving this global problem:

Demand for Foreign Products Changing FDA, Official Says
The FDA needs to shift its approach on imports to one that minimizes risk at each point in the product life cycle — from foreign manufacture to domestic use, according to Timothy Ulatowski, director of compliance in the agency’s Center for Devices and Radiological Health. The FDA will release a draft guidance soon that outlines standards for third-party certification programs for FDA-regulated products, he said. It also is preparing a draft guidance on good importer practices.

A New "Double-Dose" Pill Drug Recall Is Issued By ETHEX Corp.
ETHEX Corporation announced today that it has voluntarily recalled three specific lots (77946, 81141 and 81142) of Dextroamphetamine Sulfate 5 mg tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as about twice the labeled amount of the active ingredient.

FDA To Open Multiple Inspection Offices Abroad By Year-End
The U.S. Department of Health and Human Services will send the first FDA inspection teams to new offices in China, India, Europe, and Latin America before the end of 2008, according to HHS. "In the past year, we've upgraded labs and equipment, hired additional staff, and begun implementing product safety agreements with key trading partner, including China," stated HHS Secretary Mike Leavitt.

FTC Breaks Up Spam Network Which Illegally Sold Drugs Online
The Federal Trade Commission said Tuesday that it has broken up a global spam network responsible for sending billions of illegal messages encouraging consumers to buy unsafe male-enhancement and weight loss pills. The spam network, which processed credit card information in Cyprus and Georgia, used servers in China to host its websites. The FTC said the network used by this operation compromised tens of thousands of computers around the world and was capable of sending up to 10 billion spam messages per day. The bogus drugs were shipped from China and India.