Medical Devices and Prescription Drug Policy

A bipartisan group in Congress is intensifying pressure on the Food and Drug Administration (FDA) to limit the availability of addictive painkillers. 

Lawmakers urged the U.S. Postal Service Wednesday not to enact reforms that would prolong the delivery of mail-order prescriptions.

A group of 88 House members, mostly Democrats, expressed concerns that some patients might suffer under the U.S. Postmaster General's plan to impose a five-day delivery schedule for letters. 

"Whether it is a homebound senior that cannot walk or drive to the pharmacy, or a veteran who lives in a rural area with limited access to the prescription drugs they need, all of these home-delivery beneficiaries cannot afford to go without their medications for days," lawmakers wrote in a letter to Postmaster General Patrick Donahoe.

The pharmaceutical industry's leading trade group pushed back hard against President Obama's renewed call to slash Medicare payments for prescription drugs.

Obama outlined healthcare savings in his State of the Union address Tuesday night, which included a plan to "reduce taxpayer subsidies to prescription drug companies." It was a veiled reference to his proposal to offer rebates in Medicare Part D — the part that pays for drug coverage.

“The president has again proposed to upend the successful Medicare Part D prescription drug program by imposing government price controls on it," the Pharmaceutical Research and Manufacturers of America (PhRMA) said in a statement. "The facts about Part D are simple and do not support this radical proposal."

The Food and Drug Administration (FDA) is moving forward with an aggressive effort to spur the innovation of drugs that treat Alzheimer’s disease.

The FDA issued a nine-page guidance to drug-makers with recommendations on how to develop drugs aimed at treating the disease before memory loss and brain damage occur.

The device tax from President Obama’s healthcare law took effect at the start of 2013.

Budget sequestration will severely curtail operations at the Food and Drug Administration (FDA) if cuts hit the agency March 1, analysts said Tuesday.

Consulting firm Avalere Health warned the FDA on Tuesday to prepare for the 5.1 percent automatic cut in case lawmakers do not act to stop it. The reduction would amount to $210 million in 2013, according to the White House.

"In the event of sequestration, FDA may lack the critical resources needed for the timely review of important medical products that patients depend on to address their health needs," Avalere wrote in a memo. 

Former Sen. Russ Feingold (D-Wis.) launched a petition Tuesday slamming drug maker Amgen for a controversial lobbying win in the recent "fiscal cliff" deal.

In an email to supporters of his political group, Progressives United, Feingold called on Amgen to "give back" the $500 million it will make from language that delayed Medicare price controls over one of the firm's drugs. The New York Times previously reported that Amgen was the only company to lobby for the provision.

"This is lavish and corrupt corporate welfare at its most insidious, and it's not just a problem with Washington. We may not have our own lobbyists, but Amgen owes it to us — their customers — to use their own expensive lobbyists to give back the very giveaway they just wheedled out of Congress," Feingold wrote. 

Greater use of "preferred" and "limited" pharmacy networks could save taxpayers $115 billion over the next 10 years on prescription costs, according to a new study.

Healthcare consulting firm Visante projected major yields for Medicare, Medicaid and commercial health plans if they move away from "open" networks, where all participating drugstores offer basic discounts.

"Preferred" and "limited" networks operate by urging consumers to use pharmacies that offer the best discounts. 

Drug maker Amgen is defending a change in Medicare payments included in the recent fiscal-cliff deal and pushing back against a new bill to repeal that change.

Rep. Peter Welch (D-Vt.) introduced a bill Wednesday to repeal a delay in Medicare price controls for a class of drugs for kidney dialysis patients. The New York Times reported that Amgen was the only company to lobby for the change.

But the Government Accountability Office — Congress's nonpartisan investigative arm — had also recommended the delay in price controls, Amgen said.

Rep. Peter Welch (D-Vt.) introduced a bill Wednesday to repeal a special deal that drug maker Amgen secured in the recent "fiscal cliff" deal.

The New York Times reported over the weekend that Amgen had secured a deal to delay Medicare price controls over one of its drugs. The deal does not mention Amgen by name, but applies to a class of drugs that includes a profitable dialysis drug that Amgen manufactures.

Amgen was the only company to lobby for the provision, the Times reported.

Welch proposed repealing the deal, which he said will cost Medicare almost $500 million over the course of the two-year delay.