Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Wednesday, April 4, 2012

Global Regulation: IOM report on Medical Products

The press release of this IOM report was on CSPAN2 today and medical products (including devices) were a larger topic of conversation.  There was a particularly useful chart of overlapping circles that indicated that patient safety would be bolstered by this concerted & coordinated global effort.  Access to market would be an incentive for industry to apply scientific and ethical practices that benefit us all.  Warranty/liability was also a topic.  Congress must drive these changes.


Institute of Medicine says US and peers must assist developing nations on food and drug safety
By Associated Press, Updated: Wednesday, April 4, 12:49 PM
WASHINGTON — Food and drug regulators in the U.S., Europe and other developed countries should offer training, technology and expertise to developing nations in Asia, Latin America and other regions to better assure the safety of imported products, states a new report.
An expert panel assembled by the Institute of Medicine recommends the U.S. Food and Drug Administration work with counterparts throughout the world to secure supply chains for imported food and drugs, which increasingly cross borders. More than 80 percent of pharmaceutical ingredients are imported from abroad, as well as 85 percent of the seafood consumed in the U.S., according to federal figures.
“The integrated global economy demands cooperation across borders — to thwart terrorists, reduce environmental hazards, and ensure that our food and medical products are safe and effective,” states the 300-page report released Wednesday.
The report comes one day after the FDA announced a new investigation into counterfeit vials of the popular cancer drug Avastin sold to U.S. doctors. U.K. regulators said Wednesday the product was purchased from Turkey by licensed U.K. distributors. The counterfeit Avastin is the second batch to make its way into the U.S. in the last two months. The agency began investigating a similar case in February that has been traced to the Middle East, though the original country of origin is unclear.
Previous import safety scares have involved contaminated seafood, pet food and blood thinning drugs from China.
The 12-member panel of experts recommends the U.S. and its “technologically advanced counterparts” in Europe, Canada and Japan share inspection duties for facilities in developing countries.
“There is no need for American and European inspectors to examine the same facilities, especially when a vast number of facilities go uninspected,” the committee said.
The FDA has taken steps to boost inspections of foreign facilities in recent years, while acknowledging it will be impossible to visit every source of imported goods. The agency is responsible for imports from more than 300,000 foreign facilities in 150 different countries. A 2010 report by the Government Accountability Office reported that FDA inspected fewer than 11 percent of the plants on its own list of high-priority sites.
The Institute of Medicine is a nonpolitical group of experts that advises the federal government on medical issues. Its recommendations often make their way into laws drafted by Congress and policies implemented by federal agencies. The new report was requested by the Food and Drug Administration.
Report Release: Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad
April 4, 2012 (1:00 PM Eastern)
The National Press Club (The First Amendment Lounge) • 529 14th Street, NW, Washington, DC 20045 Map


The Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries will release its report, Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad, on April 4th at 1 p.m. EST.  The report release will be at the National Press Club in the First Amendment Lounge.  Please e-mail Meg Ginivan at to RSVP.
If you are unable to attend the event, there will be an open conference line to listen to the release.
To call in, please dial: 1-888-537-7715
International callers, please dial: 1-334-323-9858
Participant code: 20495372 #

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