By Frank Fazio

"Forewarned, forearmed; to be prepared is half the victory." – Miguel de Cervantes

Ink-like clouds suffused over our nation’s capitol as a murder of crows converges upon fresh carrion. As the atramentous nebulae congealed over the Hill, the icy, soul-sucking breath of regulators chilled the device industry like Harry Potter’s tormenting dementors. Yes, my friends, Congress is coming and it has medical devices locked in the cross-hairs.

There is no subtlety as the portents blaze like neon along a moonless desert highway. In 2011 there were four congressional subcommittee hearings on the FDA’s regulation of medical devices. Unsatisfied with their colleagues on the other side of the aisle, Democrats, led by Henry Waxman (D-CA) as ranking member of the Committee on Energy and Commerce (" the Committee"), have been advocating increased regulation of medical devices. In an October 12, 2011 letter to Fred Upton (R-MI), Chairman of the Committee, Joseph Pitts (R-PA), Chairman of the Subcommittee on Health, and Cliff Stearns (R-FL), Chairman of the Subcommittee on Oversight and Investigation, Waxman and colleagues Frank Pallone (D-NJ), Diana DeGette (D-CO) and John Dingell (D-MI) urged the Committee to hold hearings on device safety in conjunction with the impending reauthorization of the medical device user fee program. The letter detailed safety concerns with brain stents and metal-on-metal hip implants. Waxman et al. contended that the hearings held in 2011 focused on delays in approval and overregulation while ignoring serious health concerns. You can read the full here.

A second letter was sent on January 20, 2012 by Waxman, DeGette, and Dingell renewing their prior request for hearings. This communication detailed concerns over the “Lap Band” gastric band and urogynecologic surgical mesh. The authors concluded by requesting the Committee hold hearings to determine “whether FDA device regulation has been ineffective in protecting the public from dangerous medical devices” and urging the Committee to obtain documents in regard to the Lap Band and surgical mesh. Waxman again tied this review into the reauthorization of the Medical Device User Fee Act noting that “we [Congress] need to understand the safety of devices on the market, the tactics device manufacturers and others use to market these devices, and the extent to which these tactics may increase risks.” Full text of letter here.

If you remain doubtful that Democrats are setting up device safety as an election year issue, then you likely missed President Obama’s State of the Union Address. Buried deep in the President’s remarks, it inconspicuously passed in a heartbeat. But it was there and worthy of repeating:

“We’ve all paid the price for lenders who sold mortgages to people who couldn’t afford them, and buyers who knew they couldn’t afford them. That’s why we need smart regulations to prevent irresponsible behavior. Rules to prevent financial fraud, or toxic dumping, or faulty medical devices, don’t destroy the free market. They make the free market work better.” President Barack Obama’s third state of the union address to Congress, January 24, 2012.

It was there. Just four days after Representative Waxman’s second letter to the Committee, the President slipped device safety regulation into the State of the Union. There can be no doubt that democrats are setting this up for an election year showdown. Although the President’s remarks are couched in terms of safety, Waxman specifically tied safety into marketing tactics. There is certainly evidence that impending regulation will not simply address safety in the approval process but will further impose stricter regulatory oversight of device marketing.

You have been forewarned. In the immortal words of Rubeus Hagrid, “It’s changing out there. … There’s a storm coming, Harry. And we all best be ready when she does.”

Frank Fazio is vice president of distribution & licensing services for Porzio Pharmaceutical Services LLC. He works with both emerging and established pharmaceutical companies in obtaining the necessary state distribution licensure for legend and controlled drugs, medical devices, and over-the-counter products. A seasoned litigator, Mr. Fazio also defends manufacturers in pharmaceutical and medical device product liability litigation.