The Backstory at CDG

FDA's New Sentinal Initiative for Monitoring Device (and Drug) Safety

In a Press release issued 22 May 08, HHS Secretary Mike Leavitt announced new efforts to help FDA improve the safety and quality of medical products. By 2014 FDA will proactively access Medicare Part D (drug reimbursement) information and private-payer information to determine what, if any, adverse events have occurred. The report is available at: http://www.fda.gov/oc/initiatives/advance/reports/report0508.html.

I have more reactions to this as a consumer than as a professional. I know first hand that delayed-type hypersensitivity reactions are underreported. My own allergic reactions were reported and were, frankly, boring to my doctors once they determined that I would live. Furthermore, it wasn't clear what caused the problem, I was exposed to half-a-dozen medical devices during a procedure, any of which could have been the sensitizer. Since there was no way to know, no one knew what to report, including me.

Accessing masses of data and looking for patterns may be the best way to identify what's causing what--both for drugs and devices. It's a little 1990-ish to have the FDA looking at my private medical information, yet a practical necessity for the safety of all. 

The CMS final rule and a related fact sheet may be viewed at www.cms.hhs.gov/PrescriptionDrugCovGenIn/08_PartDData.asp

FDA Globalization Act - Coming Soon

The FDA Globalization Act was introduced in Congress this month by Congressman John Dingell. If passed, the Act will have several implications for medical device manufacturers. Among them: 1) manufacturers will be assessed a registration fee when registering their manufacturing facilities, the funds will help pay for many new federal requirements, 2) manufacturing sites will be inspected immediately upon receipt of the registration fee, 3) the plant will be inspected again when the establishmet begins to manufacture, 4) no Class II or Class III device may be imported before initial inspection, 5) device labeling must indicate the country of manufacture, 6) commercial importers will be required to register and pay a fee, 7) manufacturing sites will be issued a unique identification number following registration, and the registration ID number may be used for other purposes, and finally 8) the Secretary shall establish and maintain a corps of inspectors dedication to inspection of foreign manufacturing sites.

I applaud the requirements, both as a consumer and as a consultant. As a consultant I have seen, first hand, some of the poorly manufactured products that are imported from certain foreign manufacturers. And as a consumer I have worried for my family's health. 

Global trade has been good for me and my consulting business. It has brought in foreign Clients. It has exposed me to other ways of thinking. It has given me an opportunity to travel the world in a way that I would not have been able to otherwise. But globalization has come at a cost, and one cost has been the safety of our own medical products. This is unacceptable because, ultimately, it is a direct threat to me.

FDA has been weakened under the Bush administration, it has too few inspectors and reviewers and is losing its most experienced people. That is a loss for all of us and it is time FDA be strengthened and reinforced.   

Here is the link, in case you want to read the draft Act for yourself:
http://energycommerce.house.gov/FDAGlobalAct-08/Dingel_60AXML.pdf

The GAO and FDA

It's about time somebody stood up for FDA and screamed that they don't have enough people or the right people to do their jobs. The people I know at FDA are hard-working and thoughtful individuals; they really worry about whether or not they are doing the right thing. But I can tell from the stress in their voices that they are over-burdened and short-handed.

I hear it from Clients, too. I hear about reviewers who don't know the device technology; about reviewers who are fresh out of college, and about reviewers asking for new clinical data on minor design changes to old devices.

The latest was a reviewer who was insistent that a sponsor violate every subjects HIPAA rights in order to collect additional data after that the IDE trial was finished. The reviewer was demanding something that was both impossible and illegal.

As a professional in this industry and a consumer of healthcare, I am invested in a better, stronger FDA from both perspectives. So I say HURRAH to the GAO, hurrah to Kennedy and Waxman, and yes let's pump more money into FDA. A strong, well-funded, well-trained FDA is good for all of us. We'll get faster approvals and safer products.