One thing is for certain: The top web stories for our newsletter in the year it switched to daily publication certainly ran the gamut. Police arrested a top FDA medical regulator in a prostitution sting. Stryker ($SYK) began layoffs ahead of the medical device tax. Johnson & Johnson ($JNJ), snared in hundreds of lawsuits over a vaginal mesh implant, apparently sold the controversial device for three years before gaining FDA clearance. The FDA cited Siemens Healthcare's diagnostics arm for marketing a test system without a PMA. And Roche ($RHHBY), after a failed bid for diagnostics company Illumina ($ILMN) earlier this year, disclosed that more than 60% of its pipeline drugs will come paired with companion diagnostics.
The stories reflect a wildly diverse industry fighting to evolve in a changing marketplace. But they also remind us that device and diagnostics companies sometimes fall short in their mission, and conflict with regulators' push to maintain a level of safety and quality. The industry also faces pressure from tax laws that can sometimes become hostile to their growth and future--and readers of all stripes are drawn to those themes. In the case of the prostitution sting, our readers follow the FDA very closely, but that also clearly combined with the universal curiosity of everyone wanting to know when a person in authority gets arrested, and why.
Here are FMD's top 5 stories on the web for 2012:
1. FDA's Bill Maisel arrested in prostitution sting.
This story drew our largest number of individual hits by far. Readers are drawn to stories about crime, even more so when public figures are involved. But they also pay close attention to the FDA and its leaders. Bill Maisel is the Center for Devices and Radiological Health's well-regarded deputy director for science, and was charged in August with four counts of prostitution and one count of disorderly conduct as part of a July 13 sting in Laurel, MD. In leadership roles at Beth Israel Deaconess Medical Center and Harvard Medical School, he has long pushed to beef up FDA oversight and device safety and has continued the fight since joining the FDA in August 2010. Maisel had been scheduled for trial in September, but coverage of the issue dropped off the radar in the weeks following. The FDA, which declined to comment on personal matters, confirmed to FierceMedicalDevices that Maisel remains at the agency.
2. Stryker starts layoffs ahead of device tax.
Readers have followed this issue intensely, considering that many in the industry have argued that the 2.3% device tax, slated to begin Jan. 1, 2013, will stifle innovations and kill jobs. Some early signs of the job part of the equation started taking place in June--5 months before the November U.S. presidential election--when Stryker announced plans to begin rolling layoffs at two New York facilities and close them by the end of 2012. In all, Stryker will eliminate 107 jobs at those plants as part of a 5% overall workforce reduction and reduce operating costs by $100 million. Stryker said this was necessary to offset anticipated costs incurred by the device tax, and companies including Medtronic ($MDT), Boston Scientific ($BSX) and Zimmer ($ZMH) all said the tax would hurt their earnings, too.
3. J&J lawsuit bombshell: Company marketed vaginal mesh minus FDA nod.
Johnson & Johnson is already up against hundreds of lawsuits concerning the safety of its Gynecare Prolift vaginal mesh implant. But as Bloomberg reported in March, the company had to deal with the revelation that it apparently sold the controversial device for three years before gaining FDA clearance. In short, regulators disagreed with J&J's insistence that it could begin selling the device as it did in March 2005, because it was similar to the company's already-approved and marketed Gynecare Gynemesh. Two years later, the FDA decided J&J was wrong and required subsequent data before formally clearing Prolift and its successor device in May 2008. The revelation means J&J may have to settle the lawsuits at serious cost to the company, and industry watchers followed the news intensely.
4. FDA slams Siemens for marketing test without PMA approval.
Some of our most-read stories involve FDA warning letters, in part because they reveal how major companies sometimes fall short in their manufacturing and quality control, or skirt the regulatory approval process, and this one drew tremendous interest when it first ran in June. Essentially, the FDA cited Siemens Healthcare's diagnostics arm for marketing a diagnostics test system without having a premarket approval or investigational device exemption. The ADVIA Centaur iPTH immunoassay is used for everything from allergies to anemia and hepatitis, and regulators also faulted the company for not having an adequate system in place to ensure proper manufacturing. Siemens said the company was working hard to address all of the FDA's issues.
5. Roche bets big on companion diagnostics.
Personalized medicine is poised to change healthcare as we know it. And drug companies rushing to develop new, targeted treatments have been racing to develop companion diagnostics to go along with them. That's why Roche CEO Severin Schwan generated huge news when he said in September that more than 60% of the company's pipeline drugs will come paired with companion diagnostics. Roche has paid serious attention to beefing up its diagnostics focus, and made an ill-fated $6.7 billion bid to acquire Illumina earlier in the year in order to reach that goal. But since then, much of the company's diagnostics expansion has happened in house. Roche has subsequently invested substantially in its diagnostics division, with an eye on the inevitability of pairing companion diagnostics with most major drugs down the line.
-- Mark Hollmer (email | Twitter)