Medical Device Daily Washington Editor

The announcement that Sen. Ted Kennedy (D-Massachusetts) succumbed to cancer marks the end of an era for the first family of American politics, at least where the first generation of that family is concerned, but Kennedy's death also removes a piece of the healthcare legislation puzzle that may end up being seen as essential in efforts to move a bill out of the Senate. Kennedy, long known as a liberal with a willingness to bargain with his political opponents and allies in order to move legislation along, does not seem to have a successor in the Senate with sufficient chops to forge the compromises necessary to resolve the healthcare debate.

In an interview with Medical Device Daily, Joseph Antos, PhD, a healthcare scholar with the American Enterprise Institute (Washington), said the initial reaction "is an emotional sort of thing and I'm sure people – not just proponents of reform – are saying what a great man he was. And in many ways he was."

Still, where healthcare reform is concerned, "none of the facts have changed," Antos said, and the loss of Kennedy will not help move legislation along. "Where Ted Kennedy could have been pivotal is in the trenches, getting people, especially on his side of the aisle, making accommodations," he said.

The White House has attempted to distance itself from the bare-knuckle legislative action, but some observers are of the view that President Obama needed Kennedy's help in order to get legislation passed. "I didn't used to think so," Antos said, adding that he began to change his mind when it became apparent that Obama's recent talks about healthcare "do not seem to have brought people together."

Kennedy is, indeed, a difference maker, as the saying goes. "The proof is the Massachusetts [healthcare] reform. Ted Kennedy is the reason their reform happened. He went to union leaders who were opposed" and got them on board, Antos said. "Only Ted Kennedy could have done that. He brought the left in Massachusetts close enough to the middle that a deal could be done with [Governor Mitt] Romney."

"Kennedy's loss is a major blow to getting anything out of the Senate," Antos observed, but said, "once the shock wears off, Democrats and Republicans will realize that they still have their work cut out for them."

With Kennedy gone, Senate majority leader Harry Reid (D-Nevada) has a dilemma to deal with. Without Kennedy to bridge the rather wide chasms in the healthcare reform debate, Reid will be split by the urge to keep the Democratic Party's far left wing on board and the necessity of keeping at least a few members of the GOP in play. The alternative, budget reconciliation, is not known as the nuclear option for nothing.

Hence, Reid may have to put the Senate Finance Committee's bill up for a vote before offering a bill written by the Senate Health, Education, Labor and Pensions Committee. Antos said, "I don't think he has much choice, but would it be exactly the bill that [Senate Finance Committee chairman Max] Baucus reports out? Probably not, because Reid's job is to find a compromise between" the two bills," he said.

One of the tricks in that compromise will be coming up with a response to the government-run public option for insurance coverage, an idea Antos said does not seem likely to fare well in the Finance Committee's bill. "I think feelings are strong enough against the public plan that at most it would be a weak co-op idea," he said, an idea that the committee's members might go for because the so-called Gang of Six are mostly from rural states that have various types of co-ops "and that's a positive sounding term for rural senators."

Still, it is likely that personal relations are crucial to carrying the day. Antos noted that Baucus "has a long record of following the reasonable order in the Senate and if he thinks it's possible" to strike a particular deal, he will try, but Antos also noted that Baucus and the committee's ranking GOP member, Chuck Grassley (R-Iowa), have long worked together. "Personal relations are always the crucial ingredient in negotiations," he said, adding that Baucus, Reid and Chris Dodd (D-Connecticut), the acting chairman of the HELP committee, "don't look all that close."

Supreme Court to hear Bilski Nov. 9

The Supreme Court has posted the date for arguments for the business method patent case of Bilski, which has stirred up a fair amount of controversy among members of a number of industries.

The case revolves around a patent application dealing with the hedging of risk of agricultural commodities trades, which the Patent and Trademark Office declined to patent, a position upheld by the Court of Appeals for the Federal Circuit, although for a slightly different set of reasons. The Advanced Medical Technology Association (AdvaMed; Washington) weighed in on the matter in friend-of-court briefing (Medical Device Daily, Aug. 10, 2009) in which AdvaMed states that the unavailability of method patents "creates uncertainty regarding" patent eligibility, even so far as existing patents are concerned. That uncertainty, the authors assert, "will deter critical investment in the biotechnology and medical technology industries."

FDA update for third party inspectors

FDA has added a few requirements for entities wanting to participate in the third party inspection program, which has not had the impact long anticipated.

According to the Aug. 6 statement, released yesterday, contract inspectors must be able to demonstrate knowledge of the Federal Food, Drug and Cosmetic Act and the Public Health Service Act, as well as the associated regulations. Inspecting entities must henceforth also have "the capability to interface with FDA's electronic data systems and IT systems to safeguard "trade secrets and confidential commercial information." Conflicts of interest that are barred now include spouses or minor offspring who have any financial interest in "any product regulated under the act."

Mark McCarty, 703-268-5690; mark.mccarty@ahcmedia.com