The medical device industry likes to complain that the Food and Drug Administration’s efforts to regulate its products have become too heavy handed.
As it turns out, the agency is just getting started.
In a letter sent Tuesday to makers of external defibrillators, the FDA “strongly recommends” companies meet with the agency to discuss, among other things, ways to improve the design, manufacture and controls of the devices.
The FDA says it’s concerned with a growing number of recalls related to external defibrillators — 19 recalls last year compared to seven in 2005. In July, the FDA issued a Class I recall — the agency’s most serious type of recall — relating to products made by Physio-Control Inc. a subsidiary of Medtronic Inc. (NYSE:MDT), based in Fridley, Minnesota.
“Many of the types of problems we have identified are preventable, correctable and impact patient safety,” the letter says. “We have concluded that there are numerous problems with industry practices for designing and manufacturing defibrillators, handling user complaints, conducting recalls and communicating with users.”
In addition, the FDA is partnering with the University of Colorado to “provide the infrastructure to allow development of innovative [defibrillator] features, such as automated integration into local 9-1-1 systems.”
Instead of merely encouraging innovation, the agency apparently is getting into the innovation business itself.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
That alarms people like Mark DuVal, founder of DuVal & Associates, a Minneapolis-based law firm that specializes in FDA matters.
“Since when is it FDA’s mission to do this?,” DuVal wrote in an e-mail to Minnesota’s medical device community. The FDA “continues to divert its precious resources and confuse its mission by getting distracted and writing a larger unintended role for itself.
“Industry can and will develop and bring products to market,” DuVal continued. “We need to get FDA out of the development business and back into the approval business!! FDA needs to do its job… Clearance and approval numbers are down. Innovation and investment in innovation are hurting jobs [that] are being lost overseas, and FDA is getting into the business of medical device development.”
DuVal ends on a sarcastic note:
“Being cynical: frankly, I don’t know why industry just doesn’t hand everything (idea discovery, development, clinical testing, regulatory is a no-brainer, reimbursement and marketing) over to the experts — the FDA.”
According to its website, one of FDA’s jobs is “advancing the public health by helping to speed product innovations.”
Judging from DuVal’s e-mail, however, the industry is getting a little weary of the FDA’s “help.”
