Congress takes up follow-on biologics bill
The long-awaited breakthrough for follow-on biologics may be close at hand.
Prompted by a far more supportive President and the growing crisis in healthcare funding, Congress has again taken up the call for a bill that would create a regulatory pathway for FDA approval of generic versions of biologically-engineered drugs. And with the strong affirmation of President Obama, who has campaigned for such an approval pathway, the newest iteration of the bill stands a far better chance of passage than previous attempts in the House and Senate.
The Promoting Innovation and Access to Life-Saving Medicine Act could mark the most significant change to the delicate balance of power between the branded and generic drug industries since passage of the landmark Hatch/Waxman compromise bill in 1984, which ushered in the modern era of me-too medicines. Tellingly, one of the new bill’s sponsors is an architect of that 1984 legislation, Democratic Rep. Henry Waxman of California.
The push for follow-on biologics augers well for both health plan payers and patients coping with the sometimes staggering costs of critically important but expensive pioneer biologics, and for the generic drug industry itself as it faces a critical shortage of new marketing opportunities as the number of blockbuster drugs facing patent expirations dries up. A new pipeline of me-too biologics could help fill the gap.
“With countless patients struggling to pay the high costs of brand biopharmaceuticals, an approval pathway for safe, effective and affordable biogeneric medicines that provides access sooner rather than later is desperately needed,” stated Kathleen Jaeger, president and CEO, Generic Pharmaceutical Association.
Cost-saving considerations aside, there’s no disputing the business potential follow-on biologics represent. Bio-engineered pharmaceuticals and specialized, highly targeted medications aimed at serious chronic or life-threatening diseases represent the only major bright spot right now in the global pharmaceutical market, with growth rates that far outpace the sluggish market for mainline meds. Indeed, most of the drugs that have reached blockbuster status in recent years have been biologically engineered specialty meds.
Lack of sleep can increase risk of diabetes, study shows
BUFFALO, N.Y. Insufficient sleep every night can increase the risk of diabetes, a new study shows.
Researchers at the University of Buffalo in New York found that people who sleep less than six hours a night are 4.5 times more likely to have elevated blood sugar than those who get six to eight hours of sleep. A fasting glucose level of more than 100 is known as prediabetes.
The researchers presented their findings at the American Heart Association’s 49th annual Conference on Cardiovascular Disease Epidemiology and Prevention.
The findings were based on data from a six-year follow-up of patients who took part in the Western New York Health Study, conducted between 1996 and 2001. The 91 people who started out with normal fasting glucose levels but later developed pre-diabetes were compared to those who maintained normal glucose. The study participants were placed into three groups: those who slept less than six hours, those who slept more than eight hours and those who slept between six and eight hours.
“This study supports growing evidence of the association of inadequate sleep with adverse health issues,” said study lead author Lisa Rafalson. “Genetic susceptibility is always a possible explanation for this finding, but it is more likely that pathways involving hormones and the nervous system are involved in the impared-sleep [and] fasting glucose association.”
PhRMA: White House Healthcare Summit “offers opportunity for input into reform”
WASHINGTON An organization that represents the drug industry said Thursday that the White House’s healthcare summit in Dearborn, Mich., part of a series that will include several cities, “offers opportunity for input into reform.”
“Through a series of White House health reform summits taking place in Dearborn and other cities across the country over the next two months, a diverse group of stakeholders – including patients, physicians, industry, labor and government – will be openly discussing key elements needed in a comprehensive healthcare reform package,” said Billy Tauzin, president, CEO Pharmaceutical Research and Manufacturers of America. “These discussions are critical to help ensure that healthcare reform remains a top national priority this year and does not fall by the wayside.”