Obama administration rejects long exclusivity periods for biotech drugs
WASHINGTON The Obama administration gave a boost to the generic drug industry Wednesday with a letter to Rep. Henry Waxman, D-Calif., rejecting calls by the biotech and pharmaceutical industries for guarantees of long market-exclusivity periods in biosimilars legislation.
The letter cited a recent Federal Trade Commission report saying that market exclusivity periods of 12 to 14 years were unnecessary to ensure innovation and competition, and that seven years would suffice. Signed by Office of Health Reform director Nancy-Ann DeParle and Office of Management and Budget director Peter Orszag, the letter was a response to Waxman’s June 8 letter responding to proposals for a regulatory approval pathway for biosimilars in the administration’s fiscal year 2010 budget.
The generic drug industry has welcomed the letter. “As Congress debates healthcare reform, the White House has sent a strong signal to members that it is critical to ensure that affordable, life-saving biogeneric medicines get to patients in need sooner rather than later,” Generic Pharmaceutical Association president and CEO Kathleen Jaeger stated. “In citing the recent FTC report on biogenerics, the president rejects attempts by the pharmaceutical and biotech industries to needlessly extend market exclusivity provisions to an unprecedented period of 12 to 14 years simply to maintain their monopolies on biopharmaceutical products.”
Meanwhile, the organization representing the biotech industry criticized the letter, calling seven years’ market exclusivity a “risky short cut” to biosimilars. “As we have consistently said, any pathway to biosimilars should provide a fair period of time for innovators to protect their proprietary data from competitors in order to promote the continued development of breakthrough medicines, therapies and cures,” Biotechnology Industry Organization president and CEO Jim Greenwood said. “We continue to believe that 14 years of data exclusivity will strike the appropriate, reasonable and fair balance between our common desire to expand access to breakthrough biotech medicines and the need to preserve the protections necessary to promote further biomedical advances.”
PCMA launches ad campaign to push Senate on biosimilars
WASHINGTON An organization of the country’s pharmacy benefit managers has launched a new ad campaign to nudge senators on biosimilars.
The Pharmaceutical Care Management Association announced Thursday the launch of the campaign, directed at members of the U.S. Senate Health, Education, Labor and Pensions committee, hoping they will include “real” biosimilars legislation as part of healthcare reform.
The ad features a photo of a toddler and the caption “Meet the first recipient of an affordable biologic for hemophilia. He’ll be 66 years old when he finally gets it.”
“If this week’s report is accurate that Washington and the drug company lobby have reached some kind of new health reform ‘agreement,’ we sincerely hope that biogenerics is not part of it,” PCMA president and CEO Mark Merritt said in a statement. “The drug lobby will truly have reason to celebrate if Washington either ignores biogenerics reform or, worse, establishes a new process that could actually forbid competition for years after patents expire.”
Medical care for pre-diabetes costs nation $25 billion annually, new data shows
WASHINGTON One-in-4 American adults suffers from a silent condition known as pre-diabetes, a condition that costs the nation $25 billion a year in medical costs, according to new data.
Studies also show healthcare costs attributed with some 180,000 pregnant women diagnosed with gestational diabetes are estimated at $623 million a year.
In response to high diabetic healthcare costs, The American Diabetes Association recently engaged The Lewin Group to build upon a 2008 study that determined the estimated total direct and indirect costs of diagnosed diabetes in the United States to be $174 billion.
“It is absolutely critical that we understand the economic impact of diabetes on the nation so that we can develop health care policies that can effectively support the necessary behavior change and aggressive medical management needed to stem the diabetes epidemic,” said Dana Haza, senior director of NCDP, an initiative created by Novo Nordisk to drive systems change at the national and local level.
The studies, conducted by The Lewin Group, can be found in the current edition of the peer-reviewed journal Population Health Management.