Medical Device Daily Washington Editor

WASHINGTON – The political climate has shifted dramatically in Washington, so it's no surprise that this year's agenda for the Advanced Medical Technology Association (AdvaMed; Washington) is dotted by concerns over a raft of legislation industry sees as potentially harmful.

The tougher question is just how successful industry will be in shaping bills that are sure to hit the Government Printing Office during the first year of the 111th Congress, such as federal pre-emption of state liability laws for non-defective PMA devices.

The association's executives and industry executives sounded hopeful during a Wednesday press conference about avoiding the worst possible outcomes on many of these concerns, including bills dealing with patent reform and payments to physician consultants as well as on how the comparative effectiveness question will play out over the next couple of years.

None would argue explicitly against the notion that the only thing standing between the current state of affairs for PMA pre-emption and a complete reversal is a Senate filibuster.

Don Casey, who chairs the worldwide comprehensive care group at Johnson & Johnson (New Brunswick, New Jersey), addressed some of the thornier legislative proposals that figure to make the rounds on Capitol Hill. During the press conference, he said of liability pre-emption that AdvaMed "continue[s] to affirm that the idea of a single expert body is essential," a reference to FDA's regulatory oversight of industry. He also pointed out that no law pre-empts lawsuits that allege negligence in the manufacture and handling of either PMA or 510(k) devices.

In a discussion with Medical Device Daily after the session, Casey acknowledged that the House most likely would pass such a bill with little problem. Regarding whether the Senate is the only likely backstop against efforts to end pre-emption – assuming the Obama administration would sign such a bill – he would say only that industry "continues to have a dialogue with the Senate about how we can provide the best legislation that protects access to medical technology."

As for AdvaMed's code of ethics, which the association recently amended, Casey said the effort was aimed at preventing "an erosion of trust between our industry and the patient." The code goes into effect in July for member companies, and runs more or less parallel to a similar effort by the Pharmaceutical Research and Manufacturers of America (Washington), whose code of ethics kicks in next January.

Of the Physician Payment Sunshine Act of 2009, recently introduced by Sens. Herb Kohl (D-Wisconsin) and Chuck Grassley (R-Nebraska), Casey "supports the basic premises," but said he is "concerned if there are 50 different reporting requirements."

On the subject of patent reform, Casey remarked that "most of the activity is on apportionment," adding, "we oppose that." Apportionment deals with damages awarded by suits based only on the value that an infringed patent adds to the overall value of a larger product, which device makers feel invites infringement partly because of the relatively short life cycle of many medical devices.

Casey would not address the question of whether there is any interest on Capitol Hill in a less-ambitious approach to patent reform, such as dealing with first-to-invent and venue shopping, which are issues that enjoy much broader support than some of the more controversial elements of recent legislation.

Ed Ludwig, chairman/CEO of Becton Dickinson (Franklin Lakes, New Jersey) and a former chairman of the AdvaMed board, discussed a few issues in the world of regulations, including the 510(k) program at FDA.

He asserted that despite a surge in negative coverage, the process "is rigorously scientific," adding that the GAO's long-awaited report on the process "basically confirmed that, and specifically recommended that the remaining 20 class III devices be . . . harmonized" with other class III devices into a PMA category. "We agree with that," Ludwig said. He also said that the GAO report repudiates charges that the 510(k) process does not work.

Regarding the industry's prospects in other nations, Jim Mazzo, CEO at Advanced Medical Optics (Santa Ana, California), which is being acquired by Abbott (Abbott Park, Illinois), said the reimbursement picture in Japan is shifting. He said industry deserves "a lot of credit in that we've reduced the time needed to introduce our products" by means of user fees that have helped to nearly triple the number of product reviewers from 35 to 104.

Addressing the European market, Mazzo also remarked that AdvaMed members are "pleased that the commission has decided to postpone a recast of the Medical Device Directive."

On the subject of China, Mazzo said he is "encouraged by steps they've taken to reform their healthcare system," including a recent expansion of healthcare coverage and the decision to phase out product testing he said was redundant of bench testing already applied to exported U.S. devices.

"Advamed is being proactive with [the State Food and Drug Administration] to ensure the highest standards are practiced in China," Mazzo said, adding that SFDA is looking closely at the regulatory proposals under consideration by the Global Harmonization Task Force as a template for development of its GMP system for medical devices.

AdvaMed officials also voiced support for comparative effectiveness studies called for in the recently-passed economic stimulus package, but warned against using the data to make healthcare cheaper, but not better. The association's president, Stephen Ubl, said "we must guard against an innovation blind spot" incurred by attempts to "bend the cost curve."

"Too often, some view innovation as a problem" where cost control is concerned, he said, adding that the value of med-tech on healthcare is "pretty stunning."

Ubl said that a recent study conducted by the University of Chicago (UC; Chicago) indicates that "life expectancy increased by more than 3 years" between 1970 and 1998 thanks to advances in cardiovascular device technology, while adding roughly $2.6 trillion a year to the national wealth.

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