Medical Devices and Prescription Drug Policy

Rep. Mary Bono Mack (R-Calif.) on Tuesday accused federal regulators of being asleep at the switch when they failed to issue a recall of mislabeled painkillers. 

Bono Mack said the agency knew about problems at a Novartis manufacturing facility in Nebraska for years but failed to take action until the drugmaker voluntarily closed its facility and issued a recall for over-the-counter medications in the past few weeks. 

The facility has received 12 citations for quality-control problems and 166 complaints of mixed pills in bottles since 2009, Bono Mack said.

Pharmacy benefit managers are launching a new ad campaign as Congress weighs a controversial merger between two of the industry’s biggest players.

Several lawmakers have raised questions about the proposed merger between Express Scripts and Medco, which would further consolidate the already shrinking competition among firms that manage prescription drug benefits.

The Pharmaceutical Care Management Association launched new ads Tuesday touting PBMs’ ability to lower prices for consumers and employers. PBMs negotiate discounts between drugmakers and pharmacies, while also pushing for wider use of generics and mail-order prescription plans.

Small pharmacies have a longstanding feud with PBMs, which push more business to mail-order and large pharmacy chains. Some critics of the Express Scripts-Medco merger have questioned whether consumers would actually see any savings.

The Food and Drug Administration finalized its recommendations for drug industry fees on Friday and sent them to lawmakers for their approval.

Federal officials have been working with drug makers for months to develop new user fees that fund the regulators who review the safety and efficacy of new medicines before they can get to market. The FDA is seeking to renew prescription drug user fees that expire Sept. 30 and create two new user fees, for generic drugs and more complex biosimilars.

"These final recommendations offer a great example of what can be achieved when the FDA, industry and other stakeholders work together on the same goal," FDA Commissioner Margaret Hamburg said in a statement. "At a time of greater budgetary constraint, user fees provide a critical way for leveraging appropriated dollars, ensuring that FDA has the resources needed to conduct reviews in a timely fashion."

House Republicans on Thursday announced a slew of hearings on health industry fees aimed at speeding up federal regulators' review of new medicines before they can go to market.

The Energy and Commerce health subcommittee will kick things off on Feb. 1 with a hearing on the Prescription Drug User Fee Act, which expires Sept. 30. Food and Drug Administration Commissioner Margaret Hamburg is scheduled to testify at the hearing.

On Feb. 7 the panel has scheduled a hearing on a new proposed user fee on generic drugs and biosimilars, which aims to bring in more funds to help alleviate the FDA's backlog of generic drug applications. Janet Woodcock, director of the FDA Center for Drug Evaluation and Research, is scheduled to testify at the hearing.

And on Feb. 15, the subcommittee has scheduled a hearing on the reauthorization of the Medical Device User Fee Act, which also expires Sept. 30. FDA Center for Devices and Radiological Health Director Jeffrey Shuren is due to testify at the hearing.

Sen. Charles Schumer (D-N.Y.) is urging federal regulators to be extra cautious as they decide whether to approve new super-potent painkillers.

Schumer sent a letter to Food and Drug Administration Commissioner Margaret Hamburg on Sunday, urging the agency to “proceed with great caution” as drugmakers seek approval for a pure hydrocodone product that’s reportedly 10 times as strong as Vicodin, the brand name for a compound of hydrocodone and acetaminophen. The warning follows the slaying of a federal agent in a botched drugstore robbery last weekend and comes as deaths from the abuse of prescription opioids now outnumber cocaine and heroin deaths in the United States.

“In the wake of a recent tragedy in Long Island, New York and countless other violent incidents nationally that are related to prescription drug abuse,” Schumer wrote in his letter, “I have obvious concerns about how this new drug could contribute to the growing epidemic of prescription drug abuse and its resultant crime.”

Lawmakers from both parties are seeking to curb prescription drug abuse by requiring extra training for prescribers and better monitoring of prescriptions.

In his letter, Schumer recommended that the FDA, if it approves the new drug, “undertake robust postmarket surveillance,” including monitoring of marketing and sales; require drugmakers to make the product as “tamper-proof” as possible; and look into requiring radio-frequency identification to help law enforcement track the drugs if needed.

Sens. Michael Bennet (D-Colo.) and Olympia Snowe (R-Maine) requested Thursday that the Health and Human Services Department convene a joint task force with other agencies to help identify patients at risk for adverse drug reactions.

The request was sparked by a study in the New England Journal of Medicine that found that two-thirds of hospitalizations related to drug reactions stem from four common drug medications: warfarin, insulin, oral anti-platelet agents and oral hypoglycemic agents. The task force would be charged with proposing ways to reduce unnecessary hospitalizations, such as easier-to-understand patient medication guides, care transition that helps patients understand and take their medications, coordination of electronic health records and e-prescribing.

“It seems clear that action to better educate providers and patients about these common medications and the potential for inappropriate utilization could significantly reduce the number of hospitalizations,” the senators wrote in a letter to HHS Secretary Kathleen Sebelius. “While you are already undertaking efforts to reduce costs in the health care system, we believe that, in light of this compelling data, the Department can do more to coordinate and ensure the adverse events of these everyday drugs prescribed to our Medicare beneficiaries become the exception, rather than the norm.”

The Food and Drug Administration unveiled draft guidance Wednesday on how it reviews applications for low-risk medical devices.

The FDA has been working with industry and patient advocacy groups to overhaul its so-called 510(k) program, which medical device makers complain has grown too complicated and uncertain. The draft guidance is not final and is not currently in effect, but gives stakeholders a chance to comment before the agency begins to develop its final guidance.

Comments are due by April 26, 2012.

The top Republican on the Senate Foreign Affairs Committee is warning China that its proposed price controls on medical products would hurt American companies and Chinese patients.

The letter from Sen. Dick Lugar (R-Ind.) comes as China weighs how to guarantee basic medical coverage to all 1.3 billion of its people by 2020. The U.S. medical device industry has its eyes fixed on the promising market but worries that China could opt for price controls, digging into its profits and making costly American products less competitive.

China is already a favorite target of lawmakers, who accuse it of manipulating its currency to boost exports. Locking American medical devices out of what could become the world's largest healthcare market would exacerbate those tensions.

The Food and Drug Administration has denied a petition by a reproductive-rights advocacy group that sought to lift all prescription requirements for an older version of the Plan B emergency contraceptive pill, The Wall Street Journal reports.

Departed Medicare chief Don Berwick tells Kaiser Health News that U.S. healthcare is “broken.”

Teens are swapping cigarettes for flavored mini-cigars, reports The Washington Post.

Medical-device giant Medtronic has agreed to pay the United States $23.5 million to settle claims that the company paid kickbacks to physicians.

A Glaxo unit faces fraud charges, The Wall Street Journal reports.

The Health secretary said the decision to restrict access to the Plan B contraceptive was not "about politics."