Medical Devices and Prescription Drug Policy

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.

Sen. Richard Burr (R-N.C.) said Thursday that he will delay the passage of a major Food and Drug Administration reauthorization unless the agency speeds up its approval of medical devices.

The agency agrees to review products in a certain timeframe in exchange for the industry fees that pay for reviews. Burr doesn't want the FDA to be able to stop the clock on its performance goals while it waits for more information from manufacturers.

If the FDA doesn't agree to that change, Burr warned, next year's reauthorization of the FDA's user-fee programs "will be a very slow and laborious process."

The Food and Drug Administration on Monday outlined the agenda for the kinds of science and research it wants to conduct going forward.

The report is open to comments at the Federal Register for 60 days.

"Communicating our science and research needs represents an important step in stimulating research and fostering collaborations with our external partners," said Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research. "We look forward to hearing from and working with our stakeholders."

The Senate Judiciary Committee on Thursday cleared a bill that would severely curtail pharmaceutical industry deals to delay the entry of low-cost generic drugs on the market.

The bipartisan bill seeks to put an end to the practice of brand-name drugmakers settling patent challenges from generic manufacturers by paying them to delay their products. The Federal Trade Commission has said that ending the so-called "pay for delay" deals would save American consumers at least $3.5 billion a year in cheaper medications, but the industry disputes that.

The cost of generic drugs has fallen for five straight years, according to AARP.

The seniors' group released a study Thursday that says generics' prices fell 7.8 percent in 2009. AARP has previously said the cost of brand-name drugs increased by more than 8 percent that year, though the pharmaceutical industry argues that the calculation is incomplete and doesn't reflect what consumers actually pay.

AARP's findings are based on a survey of 185 generics commonly used by Medicare beneficiaries.

AARP has been measuring drug prices for the past five years. Among the products that have been on the market that entire time, the group says, the average retail price has fallen by roughly 35 percent over five years.

House Energy and Commerce Committee Democrats sought to blunt Republican attacks on medical device regulations Wednesday by asking medical journal editors to weigh in.

Democrats point out that much of the criticism against the Food and Drug Administration's regulation of medical devices has relied on two studies that were funded by the industry and weren't published in a peer-reviewed journal. The studies argue that medical device approval is slower and more convoluted in the U.S. than in Europe.

Democrats asked the editors of three respected journals — The New England Journal of Medicine, the Archives of Internal Medicine and the Journal of the American Medical Association — to review the two studies ahead of Wednesday's hearing by the E&C oversight panel. The goal, Democrats said in a memo summarizing the editors' conclusions, was to "determine whether these studies form an appropriate basis for policymaking."

The Medicare prescription drug program has cut seniors' drug costs by more than a third since its start five years ago, according to a new industry-funded report.

The report comes as Democrats push to extract more savings from the program in a deal to raise the debt ceiling.

The report, by the IMS Institute for Healthcare Informatics, concludes that the average costs for medicines in the top 10 therapeutic classes in the Part D program declined from $1.50 to $1 between January 2006 and December 2010. The report also projects that costs will continue to decline, to 65 cents by the end of 2015, a 57 percent decrease since 2006.

The decline is due to a "very competitive Part D market environment," institute director Murray Aitken told reporters in a conference call, with "a lot of plans competing on price."

A new survey suggests hospitals are delaying treatments or giving patients subpar medicines because of a prescription drug shortage.

Slashing annual biopharmaceutical revenues by $10 billion would cost the economy 130,000 lost jobs, according to a new Battelle report unveiled as debt ceiling negotiators consider deep cuts to the industry.

The report, supported by the trade association Pharmaceutical Research and Manufacturers of America (PhRMA), also estimated that 260,000 "across sectors" would be lost from a $20 billion hit to annual revenues. The industry is particularly concerned with a proposal to extend Medicaid drug rebates to the so-called "dual eligibles" who are simultaneously on Medicare, which could raise more than $50 billion over 10 years.

"As the Administration and Members of Congress continue to discuss potential solutions to reduce our nation's budget deficit, they should take great care to not pursue policies that could result in tens of thousands of lost jobs across the U.S.," PhRMA President and CEO John Castellani said in a statement accompanying the report's release. "Nationwide, the biopharmaceutical sector supported a total of 4 million jobs in 2009, including nearly 675,000 direct jobs, according to the report. Each job in a biopharmaceutical research company supported almost 6 additional jobs in other sectors, ranging from manufacturing jobs to construction and other building service jobs to contract researchers and child care providers."

The industry is holding a 10 a.m. conference call to discuss the report.