Medical Devices and Prescription Drug Policy

Three Republican senators and a House leader wrote to drugmakers and safety-net hospitals on Monday for a "detailed accounting" of how they operate the drug discount program for safety-net healthcare providers, which has significantly expanded over the past 10 years.

The so-called 340B program now covers more than 16,500 entities, according to a recent Government Accountability Office report, almost twice the number from a decade ago. Safety-net hospitals make up most of the newly covered entities.

In addition, a Health and Human Services Inspector General report last year raised questions of program integrity without proper federal oversight of taxpayer dollars, the letters' authors write.

Supporters of a bipartisan bill to crack down on illegal online pharmacies hope they can attach the measure to a must-pass Food and Drug Administration bill later this year.

Rep. Bill Cassidy (R-La.) introduced the House version of the bill Tuesday evening. The proposal would create a registry of safe online pharmacies, with the goal of steering customers away from illegal websites and counterfeit drugs.

A similar bill in the Senate drew bipartisan support — its co-sponsors are Sens. Dianne Feinstein (D-Calif.), Charles Schumer (D-N.Y.), Jeff Sessions (R-Ala.) and John Cornyn (R-Texas).

Cassidy picked up a Democratic co-sponsor in Rep. Mike Ross (D-Ark.).

A broad range of stakeholders, including pharmacies as well as Google, support the measure, Cassidy’s office said. Cassidy is hoping to attach the pharmacy measure to an FDA reauthorization that Congress has to pass by September.

Liberal Democrats appear to have a new ally in their calls for Medicare to negotiate drug prices.

In her first question at her first budget committee hearing on Tuesday, Rep. Suzanne Bonamici (D-Ore.) asked the Medicare actuary how much the federal government could save if Medicare could use its market clout to negotiate lower drug prices, such as the Department of Veterans Affairs does. The 2003 law that created the Medicare Part D prescription drug program prohibits such negotiations.

"The VA's drug prices are up to 48 percent lower than Part D prices," Bonamici said. "So as Congress looks for ways to address cost-containment while preserving the Medicare guarantee for seniors … should we be looking at providing the Medicare program the authority to negotiate drug prices?"

The Food and Drug Administration's top medical-device regulator said the agency needs more power to block unsafe products, Bloomberg reports. The comments by Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, come as House Democrats introduced legislation this month that would let the agency reject devices that have designs based on past products that were recalled for safety flaws.

The American Academy of Pediatrics is now recommending routine vaccination of boys against the human papillomavirus, which can cause cervical cancer, Kaiser Health News reports. Meanwhile, Virginia beat back an effort to repeal its vaccination mandate for young girls, The Washington Post reports. 

Colorado is joining Washington state in putting marijuana legalization on its November ballot.

Counterfeit versions of the cancer drug Avastin found in the United States contained solvents, The Wall Street Journal reports.

The results of a study of the Wii console by the journal Pediatrics "provide no reason to believe that simply acquiring an active video game under naturalistic circumstances provides a public health benefit to children."

The Infectious Diseases Society of America and 50 other organizations have signed onto a letter urging Congress to encourage antibiotics research as part of pending user fee legislation.

Lawmakers are working to reauthorize prescription drug user fees that expire Sept. 30. The groups in their letter urge House and Senate leaders of both parties to use the bill to "address the serious and growing problems of antimicrobial resistance and the dry pipeline for antibiotic research and development."

"If Congress does not enact strong solutions, we face a future that resembles the days before these miracle drugs were developed, one in which people died of common infections, and where many medical interventions that we take for granted — including care for premature infants, surgery, cancer chemotherapy, organ transplantation, and even dentistry for some patients — become impossible," the letter reads. "Antimicrobial resistance also is placing a significant burden on our health care system — costing over $20 billion annually in health care costs according to one study. To save patients' lives, we support U.S. efforts that strive to achieve the laudable goal of approving ten new systemic antibiotics by 2020."

The nation's top medicines administrator called for close collaboration between drugmakers and federal regulators to ensure the Food and Drug Administration (FDA) is able to collect the fees it needs to review generic applications.

Speaking at the Generic Pharmaceutical Association's annual meeting in Orlando, Fla., FDA Commissioner Margaret Hamburg said proposed user fees would help cut down her agency's backlog of 2,500 applications — but only if drugmakers do their part to ensure the FDA collects the $1.5 billion it's supposed to over the next five years. The time it takes to approve new generics has nearly doubled over the past few years, because the number of applications has grown at an "outstanding rate" while resources at the FDA have stagnated.

"To properly assess individual fee amounts," she said, "we'll need you to help us identify your facilities, how many you have, the type, whether they're foreign or domestic … This is really vital for us, because to collect the correct amount of user fee revenue as negotiated with the industry, FDA needs to be able to accurately predict the number of fee-paying facilities and the number of applications."

The Obama administration took credit Tuesday for averting some drug shortages and called on Congress to take action.

The president signed an executive order last fall that gives federal regulators more power to track drug shortages, quickly approve replacement manufacturing sites and punish price gougers. Since then, White House Deputy Chief of Staff Nancy-Ann DeParle wrote on the White House blog, the Food and Drug Administration has been able to prevent 114 drug shortages.

"In part, this resulted from the administration's call for voluntary notification to the FDA of potential shortages," she wrote. "Notification of a potential shortage is crucial: With enough advance warning, FDA can take action to help stop a potential drug shortage. And since President Obama signed his executive order, voluntary notifications have increased six-fold."

The U.S. Office of Special Counsel (OSC) announced Wednesday that it is broadening its investigation into the Food and Drug Administration's alleged retaliation against nine whistleblowers.

Six current and former FDA employees are suing the agency, saying higher-ups pried into their personal email accounts and retaliated against them after they shared concerns with Congress and the OSC that the agency was approving unsafe medical devices. 

Sen. Chuck Grassley (R-Iowa) has been leading the call for answers on Capitol Hill. He said Wednesday that he and Rep. Darrell Issa (R-Calif.) personally asked the OSC to open an investigation.

A counterfeit version of the best-selling cancer drug Avastin has been found in the United States, The Associated Press reports.

The Wall Street Journal examines the DEA's crackdown on pharmacies that appear to overprescribe painkillers such as oxycodone.

The healthcare law's so-called "deaths panels" — the proposal to pay doctors to talk with their patients about end-of-life options — has broad support among Californians regardless of their political affiliation, Kaiser Health News reports.

China is expanding its list of "essential drugs" that must be procured cheaply, raising concerns of drugmakers Pfizer and Merck, who want to expand in the booming market, Bloomberg reports.

Consumers Union partnered with the American Institutes for Research and University of Maryland to launch a project to measure health insurance literacy.

A trio of House Democrats on Tuesday raised concerns with federal health agencies' enforcement efforts after a British medical journal reported that drugmakers "routinely fail" to publish the results of clinical trials within the timeframe required by law.

The study in BMJ found that only 163 out of 738 trials — 22 percent — covered by federal reporting requirements were disclosed in accordance with the law in 2009. 

In letters to the heads of the Food and Drug Administration (FDA) and the National Institutes of Health (NIH), the lawmakers argue that the "publication delays may allow ineffective or dangerous drugs to remain on the market, resulting in significant harm to patients and waste in the health care system."