I’m pretty sure the Food and Drug Administration and LifeScience Alley don’t always coordinate their events. But thanks to these two organizations, some pretty meaty drama will play out in Minnesota this week.
On Tuesday, the FDA will host a town hall-style meeting in Bloomington, Minn. that will essentially allow the local medical device community to bitch … er, I mean, offer constructive feedback to the agency about proposed changes to the 510(k) program. In attendance is Dr. Jeffrey Shuren, the newly appointed head of the Center for Devices and Radiological Health (CDRH).
Two days later, Dr. Shuren’s predecessor at the FDA, Dr. Dan Schultz, will speak at the annual MedTech Investing conference in Minneapolis.
Something tells me that Dr. Schultz will get a friendlier reception. Dr. Schultz, a longtime FDA official, was pressured to resign last year amid criticism he was too cozy with the companies he regulated. That may or not be true, but it’s pretty clear what Dr. Schultz is doing now: advising medical device companies for Greenleaf Health LLC, a regulatory consulting firm in Washington, D.C.
While Dr. Shuren is generally well respected, the agency he works for isn’t quite so popular these days with the medical device community. Companies complain the FDA is taking too long to render decisions on new technology. Under pressure from Congress and disgruntled agency staff members, the FDA has commissioned the Institute of Medicine (IOM) to review the 510(k) process. The report is due next year.
Medical device firms have a good reason to worry. There are no industry representatives on the IOM committee. And the questions the committee is charged to answer, “Does the current 510(k) process optimally protect patients and promote innovation in support of public health? If not, what legislative, regulatory, or administrative changes are recommended to optimally achieve the goals of the 510(k) process?” don’t seem particularly promising to companies who like the 510(k) program the way it is.
After all, you don’t spend nearly two years reviewing the 510(k) to find everything is fine and dandy.
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.
Dr. Shuren, for his part, is playing a delicate balancing game: trying to reassure medical device companies without promising anything. And let’s face it, Dr. Shuren is just one man at an agency besieged by critics and a lack of resources.
Dr. Shuren was the perfect diplomat during a recent interview with the Star Tribune in Minneapolis.
“Overall, there’s been a very intense and very good dialogue that’s going out about the program,” he told the newspaper. “We undertook the review in light of questions and concerns that were raised — by industry, patient groups, the health care community and our own staff. We felt the best way to address concerns is to undertake a more comprehensive assessment of the process and do it in a very public way.”
“One of the reasons we’re undertaking the assessment is because folks in industry and elsewhere raised concerns about the program having a negative effect on innovation,” he said. “We’re looking at the impact it has had on innovation, and if there has been an adverse impact, what we can do to provide greater predictability in the program.”
Drs. Schultz and Shuren. The past, present and future of the FDA all in Minnesota, the country’s medical device stronghold. Break out the popcorn and enjoy the show.
