Medical Devices and Prescription Drug Policy

The House Energy and Commerce Committee's Health panel will spend the fall focused on healthcare reform regulations and preparing for a major Food and Drug Administration bill.

Energy and Commerce released its fall agenda Tuesday. The Health subcommittee's agenda is mostly focused around the FDA — specifically, getting new products to market more quickly. The committee has already begun holding hearings on the policy changes that could accompany a must-pass FDA reauthorization bill next year.

"The. U.S. traditionally has been the leader in the medical device industry employing an estimated 420,000 Americans, but the lack of predictability and consistency at FDA currently force research and development, manufacturing and new product approvals to Europe, costing American jobs and limiting U.S. patients’ access to revolutionary new devices," the committee's agenda states.

It also says lawmakers will focus on "grandfathering" rules under healthcare reform. The law exempts existing plans from some of the law's mandates and limits the types of changes that can be made without sacrificing that exemption. The Obama administration itself has said that most plans will likely lose their grandfathered status, and House Majority Leader Eric Cantor (R-Va.) recently said the rules would be a main target of Republicans' continued opposition to the new law.

Canadian pharmacies say it's the government's $500 million fine against Google, not the online pharmacy ads that prompted it, that's harmful to Americans' health, Techdirt reports.

Association health plans sold through trade groups or other organizations of affiliated members will also have to justify rate hikes of 10 percent or more, Kaiser Health News reports.

The Obama Justice Department has been taking a more aggressive approach against people who block access to abortion clinics, using a 1994 law to bring cases in greater numbers than its predecessor, NPR reports.

South Carolina Republican Gov. Nikki Haley will reject federal funds to set up a state health insurance exchange, The State reports, potentially leaving the federal government to take over.

The pharmaceutical industry is urging lawmakers to approve new user fees that fund federal drug regulators well ahead of the current system's expiration next fall. 

The comments come as the Food and Drug Administration unveiled its proposed fees on Thursday, setting up a public comment period. The draft proposal closely tracks an agreement between drug makers and the FDA that was announced in May.

"It is critical for [the Prescription Drug User Fee Act] to be reauthorized well in advance of [the current fee structure]'s expiration in September 2012 in order to avoid a reduction in force at the FDA," Biotechnology Industry Organization President and CEO Jim Greenwood said in a statement. "Even the threat of a downsizing at the FDA would be devastating to the Agency's public health mission and its ability to review new drugs and biologics."

Consumers benefit from a form of competition between brand-name and generic drugs that many generic manufacturers believe is anticompetitive, the Federal Trade Commission said Wednesday.

The FTC released a final report on the drugs known as "authorized generics." The first generic to successfully challenge a brand-name drug’s patent gets six months on the market without competition from other generics. Federal law provides that protection as an incentive for generics to challenge brand-name drugs’ patents and come to market sooner.

The FDA is expected to announce Thursday an agreement with drugmakers to fund the agency for the next five years.

A leading consumer-advocacy group wants the government to allow generic drugmakers to update their products’ warning labels when new risks are discovered without having to first go through the time-consuming federal bureaucracy.

Public Citizen filed a petition Monday with the Food and Drug Administration urging regulators to allow generic drugmakers to update warnings and precautions on product labels, just as brand-name drugmakers can. The discrepancy came into public view in June when the U.S. Supreme Court ruled that patients harmed by inadequate warnings on generic drugs cannot sue for damages, while people who take brand-name versions of the same drugs can — an “absurd consequence” of current law, Supreme Court Justice Sonia Sotomayor said.

“The action we are requesting would bring FDA regulation in line with the realities of the pharmaceutical market and help to ensure that drug labeling provides adequate warnings to patients based on information that comes to light after the drug is approved for marketing,” Allison Zieve, director of the Public Citizen Litigation Group, said in a statement. Generic drugs account for a majority of all prescriptions, and about 90 percent of prescriptions for which a generic version exists.

The petition also urges the FDA to reiterate generic drugmakers’ obligation to inform the FDA whenever a manufacturer becomes aware of information suggesting an association between its product and a hazard not adequately disclosed on the labeling, Public Citizen said.

Rep. Don Young (R-Alaska) is the latest member of Congress to raise questions about a proposed merger between two pharmacy benefit managers.

Young raised questions about the merger of Express Scripts and Medco in a letter to Federal Trade Commission Chairman Jon Leibowitz.

Merging the two pharmacy benefit managers (PBMs) could have a "devastating" impact on community pharmacies, Young wrote. He said small pharmacies have little power when negotiating drug prices with PBMs.

"The combined 'synergies' of the merged entity may not lower drug costs," Young wrote. "It may simply create greater negotiating leverage to enable this new merged PBM to extract additional savings from other market participants, which has no guarantee of being passed on to plan sponsors and consumers."

Reps. John Conyers Jr. (D-Mich.) and Tom Marino (R-Pa.) have also raised concerns about the merger.

An amendment to the reform bill would allow drugmakers to keep their patents even if they miss filing deadlines.

A group of House Democrats urged President Obama on Thursday not to offer up U.S. policy on biologic drugs for inclusion in a trade agreement.

The healthcare reform law created an approval pathway for generic versions of biologic drugs, which are more complex than traditional pharmaceuticals. It gave brand-name biologics 12 years of protection from generic competitors.

Rep. Henry Waxman (D-Calif.) pushed hard for a shorter period. He and six other House Democrats said Thursday that the U.S. should not offer up its 12-year policy as negotiations over the Trans-Pacific Partnership (TPP). The U.S. is preparing to propose language on intellectual property for the agreement, and Waxman said biologics shouldn't be included.

In a letter to Obama, Waxman noted that the White House has proposed reducing the market protection to seven years.

"Were the TPP to ultimately contain a 12 year biologics exclusivity provision, it would impede the ability of Congress to achieve the Administration's proposed 7 year change without running afoul of U.S. trade obligations," the letter states. "We see no reason for the United States to agree to such a provision, much less propose it."

A panel of healthcare experts said Friday that the Food and Drug Administration should simply scrap one of its processes for approving medical devices and start over.

The device industry slammed the recommendations, and the FDA said it does not believe such a dramatic change is needed.

The so-called 510(k) process is "unfixable," an Institute of Medicine committee said in a new report. The process has come under fire in recent years from all sides: Consumer advocates say it doesn't do enough to ensure that products are safe, and the industry says it takes too long to get new products approved.

The IOM committee said that rather than trying to fix the 510(k) process, the FDA should start over.

"A new regulatory framework will benefit everyone — patients, healthcare providers, the medical device industry, payers, and the FDA," the IOM committee stated.