House Moves Forward on Medical Cures Bill

A package of new policies aimed at getting cutting-edge medical cures to Americans more quickly is moving forward, with House lawmakers releasing the latest iteration last week. In an effort to gain bipartisan support, Republicans slashed the draft in half from an earlier version, removing one particularly controversial section giving drug developers more time to exclusively market their products and inserting more funding for the National Institutes of Health — one of Democrats' key demands.

Lawmakers still have some major obstacles to overcome, especially when it comes to paying for the legislation. But their focus on removing barriers to the speedy discovery, development and approval of new medical devices and drugs is emerging as one of the chief bipartisan legislative efforts in Congress. The push is being led by Michigan Rep. Fred Upton, Republican chairman of the House Energy and Commerce Committee, and Rep. Diana DeGette, D-Colo., who have devoted nine hearings to the topic over the last year. Upton has said he wants to send a final version to President Obama by the end of the year.

"It is important to recognize the incredible progress of the past year and remain focused on our common goal of helping patients," Upton said at a Thursday hearing on the updated draft. "We have a chance to do something big, and this is our time." The bill includes a smorgasbord of reforms to three big federal agencies that deal with health care — the Food and Drug Administration, the Centers for Medicare and Medicaid Services and NIH.

Some of the provisions could accelerate the approval process for "breakthrough" drugs that show the most promise for treating diseases, while others would facilitate increased use of biomarkers, which are physiological measures that help determine whether a patient has a disease and how best to treat it. A big GOP priority is to give drug developers more time to recover costs and make profits after their products win FDA approval — especially if the products treat rare diseases or improve existing drugs — with the aim of creating more incentives toward drug development.

But some Democrats object that these exclusivity periods, which could last from a few years to 15 years, give drug makers a monopoly and raise costs for the federal government. The measure's first draft, which didn't win the support of DeGette and other leading Democrats, included marketing exclusivities, but they have been removed from the latest version. "This bill is imperfect and there are still many pieces that need to be worked on," said Rep. Doris Matsui, D-Calif.

The brand-name drug industry, represented by the Pharmaceutical Research and Manufacturers of America, didn't indicate its sentiment on losing the exclusivity perks. The group has said it will review the draft and is "ready to work" with the committee on the measure.

Meanwhile, generic drug makers generally applauded the draft, although they want included a policy that won't let brand companies misuse a safety strategy for approved drugs called a risk evaluation and mitigation strategy.

Generic companies complain that brand-name manufacturers have used such strategies to delay generic competition by denying access to samples for safety reasons. Generic drug makers need the samples to make copycat versions of the drugs.

Another provision that has been added to the latest version of the bill is new NIH funding for medical research. It would provide $10 billion in mandatory funding for the agency over five years. Scientists have long complained about a funding shortage for medical research projects.

"Thank you, thank you, thank you, thank you," Kathy Hudson, NIH deputy director for science, outreach and policy, told lawmakers at the Thursday hearing.

Research and doctor groups applauded the new funds, too. While it is important that NIH isn't restricted in how the money is spent, the additional dollars can help fund innovative studies, said Research America.

The American Cancer Society called the inclusion of funding "long overdue," noting that federal research dollars have declined more than 24 percent since 2008. That has forced cancer centers to halt promising clinical trials, the society's lobbying arm said.

The Association of American Medical Colleges noted that the mandatory funding is essential to finding new cures. "Research means hope for patients and families suffering from serious illnesses such as cancer, diabetes, Alzheimer's, depression and Parkinson's," the association said.

While the boost for NIH was widely applauded, it only helps the agency recoup funding lost by sequestration cuts that Congress agreed to several years ago. NIH Director Francis Collins has said the agency will lose $19 billion in funding over the next decade if sequester caps aren't lifted.