Medical Device Daily Washington Editor

The pressure on the 510(k) and PMA programs at FDA show no signs of letting up, thanks to a May 11 letter to acting deputy FDA commissioner Joshua Sharfstein, MD, from three members of congress who have taken an interest in the Menaflex 510(k) obtained by ReGen Biologics (Franklin Lakes, New Jersey).

The accompanying statement indicates that Sharfstein is re-examining the application with the possibility of withdrawing the 510(k), but the letter also states that the Energy and Commerce subcommittee on health "plans to hold a hearing to examine FDA's process for evaluating the safety and efficacy of medical devices."

The letter preceeds by less than 24 hours today's hearing on pre-emption for PMA devices in the House Energy and Commerce Committee, which has drafted the Medical Device Safety Act of 2009 to end pre-emption.

According to the statement, the three members of the House, led by Henry Waxman (D-California), chairman of the House Energy and Commerce Committee, state that "given the questions raised by the FDA scientists about the lack of data on the safety and efficacy of this device, we believe this is a prudent course of action."

The other two signers were Frank Pallone (D-New Jersey), chairman of the health subcommittee, and Bart Stupak (D-Michigan), who chairs the committee's subcommittee on oversight and investigations.

The letter follows at least three letters from dissident FDA scientists to members of Congress and the White House about alleged corruption at the Center for Devices and Radiological Health. Ironically, the letter from the three congressmen, which details the committee's investigation into the Menaflex application, indicates that the director of the Office of Device Evaluation (ODE), Donna-Bea Tillman, PhD, opted to refuse ReGen's application for a 510(k) of the device at every opportunity.

While Tillman is not specifically named in an Oct. 14, 2008, letter from the dissidents to former Energy and Commerce chairman John Dingell, that letter nonetheless cites "resistance from entrenched managers at CDRH including the Center Director and the Director of ODE." This letter alleges that Tillman and Dan Schultz, MD, director of CDRH, "seem far more concerned about ensuring their current positions and protecting and promoting their own careers and those of their cronies than they are about ensuring the safety and effectiveness of medical devices."

As might be expected, ReGen sees the Menaflex matter in a substantially different light. The firm argues that the initial review of the device as a 510(k) should not have ended with a determination of not substantially equivalent as a matter of FDA policy, a view which ODE director Tillman confirmed. The company also alleges that upon the first review for clearance, FDA did not request additional data but instead argued there were no anatomically specific predicates. The company's view is that there are other cleared collagen meshes on the market that employed predicates used in other anatomical locations.

A potentially complicating factor for Congress in this matter is that the company had recruited several members of the New Jersey congressional delegation in an appeal to FDA for the device, a group that includes Pallone.

Former FDA Commissioner Andrew von Eschenbach also apparently had a role in turning around the application's prospects, but von Eschenbach later changed his view of the situation once the story broke earlier this year, telling the Wall Street Journal that the 510(k) program is "out of control." Von Eschenbach declined to refute or confirm that characterization during an appearance at this year's recent edition of the FDA/FDLI annual conference.

The Menaflex application wound up in an advisory committee hearing (Medical Device Daily, Nov. 18, 2008), which recommended clearance by an informal consensus rather than by a vote. However, it seems unlikely that a formal vote would have produced an outcome that would have been meaningfully different.

Obama, industry offer health savings

The healthcare reform movement in Congress promises sweeping legislation on the Senate floor by no later than June, but President Obama made an announcement at the White House Monday detailing a series of voluntary reforms that will shave 1.5% per year off the pace of healthcare inflation, assuming those changes have the desired effect.

During Monday's press conference, Obama said the participants "are here because of one indisputable fact: that we are on an unsustainable course" that is financially disruptive to families, businesses and governments. Obama also noted that "half of all personal bankruptcies stem from medical expenses." Among the participants were America's Health Insurance Plans (Washington), the American Medical Association (Chicago), and the Advanced Medical Technology Association (AdvaMed; Washington).

The proposals are said to save as much as $2 trillion over the next decade, in part by reducing hospital readmissions. The mechanism expected to trim readmissions is based on the value-based purchasing concept, which in this case would consist of bundled payments for specific care episodes. That model, however, may strike some providers as the return of capitation, a notion that grew quickly and died even more quickly in the 1990s. This is projected to save $25 billion over the decade.

Another $177 billion may be saved by imposing a competitive bidding program on providers operating under Medicare Part C, also known as Medicare Advantage. In this scenario, providers would offer bids, the average of which would be used to set reimbursement rates. This is also seen as a way to reduce physician payment under Medicare Part B, but related documents do not explain the connection. Physician fees under Part B have been the scourge of cost containment efforts, with Congress intervening every time the sustainable growth rate mechanism has suggested a cut in physician fees.