Is vacation a "right" or a "bonus"?

For Germans (Europeans in general) it's the first, for Americans the second. Read this interesting article about productivity in Germany and the US. As a Dutchman, I can attest that it's true!

Keeping tabs on FDA's performance

Fortunately, the FDA does that for us, and all we need to do is to access the right webpages to find the information. This is how the FDA describes the program: "FDA-TRACK is a new agency-wide program performance management system that monitors over 100 FDA program offices through key performance measures. These measures are developed by the program offices across the FDA and reported on a monthly basis. Each quarter, monthly performance data is analyzed and senior managers present this data to FDA senior leadership." The FDA Track page can be found at the FDA website. Since I am interested in medical devices, I also look at the CDRH Premarket Dashboard.

FDA gets an F for failure to keep its MDUFMA promises

Devicemakers: FDA's Performance Not Meeting MDUFMA Commitment
Even though devicemakers are picking up a growing portion of the tab, the FDA is not holding up its end of the bargain — to be interactive, predictable and timely — that it made under the Medical Device User Fee and Modernization Act (MDUFMA). "We're seeing more and more examples where that interactive collaboration ... may be falling short," Mark Leahey, president of the Medical Device Manufacturers Association, said at a MDUFMA reauthorization meeting last week. "As it currently stands right now, I think our members would be hard pressed to support the continuation of this program."
Devices & Diagnostics Letter

Obesity - how about eating less?

Yes I admit, I'm neither obese nor overweight. But I don't understand why someone who is overweight can't simply eat less? About a decade ago I decided that I needed to lose ten pounds, so I adjusted my diet, lost the ten pounds, and kept them off.

Now sources in the UK are proposing more weight loss surgeries to contain the cost of caring for obese people - is it just me, or is something upside-down here?

Off-label usage

Off-label usage (of drugs and devices) has long been a hot topic. Companies are forbidden to market off-label uses of their products, and Allergan launched a lawsuit to object to that regulation. Unfortunately, they've dropped that lawsuit, see the excerpt below.

Allergan Drops Suit Challenging FDA’s Off-Label Enforcement
The device industry may have lost its best shot at challenging how the FDA regulates off-label use when Allergan agreed to drop its First Amendment lawsuit seeking the right to tell physicians how to safely use a product off label. The company dropped the suit against the FDA last week as part of a $600 million settlement with the Justice Department over its promotion of Botox for off-label uses. Had Allergan successfully pursued the case, device companies would be able to discuss off-label uses as long as they did so honestly and had safety and efficacy data to support the uses, James Beck, an attorney at Dechert, said.
Devices and Diagnostics Letter

We're from the government, we are here to help you...

CDRH Touts Proposed 510(k) Changes as Good News for Device Industry
CDRH is trying to sell devicemakers on suggested changes to the 510(k) process, saying the changes would increase regulatory predictability. “It is not our intent to turn the world upside down for device manufacturers,” Christy Foreman, acting director of CDRH’s Office of Device Evaluation, said during an agency webinar last week. CDRH officials promoted the upsides of a Class IIb process for 510(k) devices that are more likely to require additional clinical information, touting it as a step toward global harmonization. Having such harmonization could lead to devices being simultaneously cleared domestically and abroad, CDRH Director Jeffrey Shuren said.
Devices & Diagnostics Letter

Heather Rosecrans to retire later this month

Director of 510(k) Office Will Retire This Month
A major player in CDRH’s 510(k) process is stepping down just as the agency begins to revamp the device clearance program. Heather Rosecrans, director of CDRH’s 510(k) Office of Device Evaluation, is retiring Sept. 15, FDA spokesman Dick Thompson said. Her departure could be another example of the ongoing turnover at CDRH, John Romans, CEO of BioMedix Vascular Solutions, said, adding that the turnover has resulted in a loss of institutional memory, contributing to the lack of predictability in the clearance process.
Devices & Diagnostics Letter


Hmm, I don't know. I know Ms Rosecrans and she always was rather bureaucratic and inflexible in her dealings with me. Maybe a change would be for the better?

Do you understand this logic?

Unfortunately I don't subscribe to Devices & Diagnostics Letter, but the excerpt below doesn't make sense! I agree that the current 510(k) process is arbitrary and opaque, but surely that will hurt foreign firms more than US firms, I'd think. What is your opinion?

Lawmakers: Better 510(k) Process Key to Keeping Device Jobs in US
Trying to keep devicemakers, and the jobs they provide, in the U.S., lawmakers are urging the FDA to be more transparent and predictable in its review of 510(k)s. Delays in review times and the agency’s unpredictability in reviewing 510(k)s are hurting U.S. devicemakers trying to compete in the global market, as more countries, including China, require devices to be approved in their home country before granting them marketing authorization. As a result, some devicemakers have moved their headquarters to the EU where they can get more timely marketing approval, Sen. Amy Klobuchar (D-Minn.) said.
Devices & Diagnostics Letter