Medical Device Daily Washington Editor

FDA has issued an emergency use authorization for a diagnostic to detect swine flu, a.k.a., H1N1, made by Focus Diagnostics (Cypress, California), a wholly owned subsidiary of Quest Diagnostics (Madison, New Jersey). According to the July 24 FDA announcement, Focus's real-time reverse transcription polymerase chain reaction (RT-PCR) test is the third diagnostic for which the agency has issued an emergency use authorization, and the agency's statement indicates that the latest test "amplifies the viral genetic material obtained from swabs of the nose or throat, or from nasal discharges" to establish the presence of the virus.

The FDA statement quotes Dan Schultz, MD, director of the Center for Devices and Radiological Health, as saying, "will contribute to the nation's capacity for accurate testing for the 2009 H1N1 influenza virus."

Quest said in May that Focus had successfully developed the test earlier this year (Medical Device Daily, May 19, 2009), but the test will be regulated as a high-complexity test, ruling out use in a point-of-care setting.

In a July 24 statement posted at the Quest web site, Jon Cohen, MD, Quest's chief medical officer, said that the test, "when combined with clinical and epidemiological assessments, can aid physicians in diagnosing patients infected with the 2009 H1N1 influenza virus versus other influenza A virus strains." Cohen also said Quest would "continue to work closely with public health officials, who have done an outstanding job managing the pandemic, to mitigate its effect on public health."

Device makers not keen on rebates

Makers of medical devices were probably of the view that any contribution from their industry toward the expansion of healthcare coverage would come via reimbursement changes to hospitals, but device makers might be looking at more direct action that would impact the money paid for devices, perhaps in the form of rebates or excise taxes.

Reports of a deal between the medical device industry and the federal government began to surface last week, thanks in part to comments by device industry analyst Larry Biegelsen of investment bank Wells Fargo (San Francisco), who is on record as having said that the Obama administration has been in contact with device makers about a deal that would be inked by September. According to a number of wire service reports, Biegelsen also said that any deal "will be viewed as a net negative for investors as few expected healthcare reform to have a direct impact" on device makers. Some of the numbers that have been floated toward this end run as high as $60 billion over a decade, but Biegelsen is of the view that any concession of more than $15 billion would wipe out any gains from the expected expansion of healthcare coverage.

Mark Leahy, executive director of the Medical Device Manufacturers Association (MDMA; Washington) told Medical Device Daily that the association has had no contact with the White House on the subject, but has had contact with the Senate Finance Committee. He said that the association's members are amenable to some sort of compromise, "but a broad-based rebate or excise tax is not something MDMA could support."

Steve Ubl, President/CEO of the Advanced Medical Technology Association told MDD in an e-mailed statement that the association "remain[s] committed to the ultimate goal of achieving broad based reform that offers every American access to healthcare" and that AdvaMed is "maintaining an open line of communication and working constructively with the White House and leaders on Capitol Hill."

PTO edges toward patent e-filing

Physicians are not the only ones who have not migrated wholly to the Information Age as anyone who deals with FDA knows, and the U.S. Patent and Trademark Office is joining the list of federal agencies striving to go electronic.

In a July 21 statement, PTO reported the implementation of the e-Office Action program following a successful pilot that employed electronic communications in lieu of paper mailings for patent prosecutions. According to the PTO statement, the program includes communications dealing with provisional and non-provisional applications including "utility, plant, design, and reissue applications and national stage applications." However, international applications, reexamination proceedings, and interference proceedings are said to be excluded.

Acting PTO director John Doll said in the statement, "not only have we dramatically reduced paper processing and mailing costs but also expedited notification allowing applicants to take full advantage of their time period for reply to an office action."

Participation is optional and open to any inventor, registered attorney or agent of record involved a patent application, but participants can opt-out of the program at any time and return to snail-mail.

FTC says 'nay' to acquisition of clinics

The Federal Trade Commission has registered an administrative complaint against the acquisition of several outpatient imaging clinics by Carilion Clinics (Roanoke, Virginia), arguing that the 2008 purchase has reduced competition and boosted prices.

According to FTC, the $20 million acquisition of the Center for Advanced Imaging and the Center for Surgical Excellence (both Roanoke, Virginia), will drive up out-of-pocket costs for many patients by nearly 900% "for some treatments." FTC also alleges that the move, which leaves the Roanoke area with only two competitors for imaging services, "will lead to higher premiums and the risk of reduced coverage for needed services." FTC's July 24 statement notes that the agency seeks "divestiture of these centers and related assets necessary to restore the competition eliminated by the acquisition."

Bureau of Competition director Richard Feinstein said in the statement that competition "can help contain costs and improve quality of care." He also said that the reduced competition "will result in higher health care costs at a time when such costs already cause serious financial hardship for consumers in the Roanoke area and throughout the country."