Medical Devices and Prescription Drug Policy

Restricting certain legal settlements between brand-name and generic drug companies could save the federal government almost $5 billion, the Congressional Budget Office said Tuesday.

The CBO said a Senate bill to restrict so-called “pay for delay” settlements would cut the deficit by $4.8 billion over 10 years. That’s noticeably higher than CBO’s previous estimates of largely the same proposal — the budget office said last year that curbing the settlements would save about $2.6 billion over a decade.

A bitter fight is shaping up over drug discount coupons as brand-name drugmakers seek to entice customers by covering their co-pays.

Drugmakers and some patient advocates say the coupons allow patients to be able to afford life-saving medications. Critics counter that they're a marketing ploy meant to hook patients on expensive brand-name drugs instead of low-cost generic alternatives at a time when patent protections for several blockbuster drugs are expiring.

A new report commissioned by the drug benefit manager lobby estimates that co-pay coupons will jack up the healthcare costs by $32 billion over the next 10 years if current trends continue. The report argues that the coupons further remove consumers from the true cost of their healthcare choices by sticking insurance plan sponsors with an ever larger portion of drug coverage costs. Read more...

The pharmacy benefit giant Express Scripts toured Capitol Hill Wednesday with 50 pharmacists in tow to tout the deficit-busting potential of its pending merger with MedCo Health Solutions.

The visit comes as the Senate antitrust panel is set to hold a hearing shortly on the proposed merger, which would create the nation's largest administrator of drug benefits if federal regulators sign off. A House committee held a similar hearing last month.

"Our perception of what's happened on the Hill is that there's been a lot of noise made in the media and they are responding to their constituents and asking questions," Express Scripts Chief Medical Officer Steve Miller told The Hill. "But we believe they're going to leave this to the (Federal Trade Commission) to decide. The main reason we're up here is … we'll be dealing with the government for a long time in the future because we believe we're the solution to holding down costs and improving care."

President Obama took unilateral action Monday to help stem the nation's critical shortage of lifesaving drugs.

President Obama took unilateral action Monday to help stem the nation's critical shortage of life-saving drugs — a degree of personal involvement in health policy not seen since passage of the healthcare reform law almost 20 months ago.

The unexpected announcement garnered widespread praise from industry and patient advocacy groups, helping reverse a near-constant barrage of bad news in recent weeks that saw the demise of the health law's long-term-care program while support for the law sank to its lowest level yet. The president's order gives federal regulators more power to track shortages, quickly approve replacement manufacturing sites and punish price gougers. Healthwatch's Julian Pecquet has more.

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The Food and Drug Administration (FDA) on Wednesday awarded $2 million to support the creation of research centers tasked with improving the way new medicines and medical devices are reviewed and evaluated.

The grants will help establish two regional Centers of Excellence in Regulatory Science and Innovation at the University of Maryland and Georgetown University. The centers' researchers, according to the FDA, are tasked with assisting federal regulators in "driving innovation in medical product development as well as in advancing laboratory, population, behavioral and manufacturing sciences."

"These partnerships represent a critical, necessary and creative investment — one that will benefit not just FDA and academia, but also American consumers and industry," FDA Chief Scientist Jesse Goodman said in a statement announcing the awards. "The Centers of Excellence will create new scientific research, training and staff exchange opportunities for FDA and leading area institutions."

The centers are tied to the agency's strategic plan for "Advancing Regulatory Science at FDA," released in August.

The two first centers will be established in the Washington, D.C., area to allow for the greatest interaction between researchers and FDA staff. The agency is based in Silver Spring, Md.

Consumer advocates say Obama trade negotiators are giving brand-name drug manufacturers stronger patent protections and pricing power.

Vitter accused Democrats of opposing importation of prescription drugs from Canada because of the industry's support for healthcare reform.

The Senate on Thursday defeated an amendment that would have made it easier for individuals to get prescription drugs from Canada for personal use.

"This amendment would allow the importation of small personal-use quantities of safe FDA-approved prescription drugs from Canada alone," argued Sen. David Vitter (R-La.), the amendment's author. "It is a very modest amendment."

The measure would have prohibited the Food and Drug administration from blocking such imports.

Nevada authorities have dropped murder charges against a Las Vegas doctor after determining that a patient's death in 2007 was not caused by painkillers he prescribed, a physicians group reports.

Richard Teh's arrest in March prompted a national dialogue on doctors' criminal liability when prescribing powerful pain medication. While state and federal lawmakers are seeking to crack down on painkiller abuse — abuse of legal drugs leads to some 30,000 deaths a year, especially among children and young adults — medical professionals are pushing back against what some call out-of-control prosecutors.

"The Teh case is by no means unprecedented," Jane Orient, executive director of the Association of American Physicians and Surgeons, said in a statement. "Many physicians have been prosecuted and even gone to prison for years for the 'crime' of trying to relieve pain."

An initial autopsy of Teh's patient concluded that she died of "multiple drug intoxication." A second autopsy, however, found that drug levels in the patient's body were below toxic levels and that she died of a bacterial infection.