House Boosts Funding for Medical Research

The bill, which won overwhelming support from both Republicans and Democrats, would increase funding for the National Institutes of Health by $8.75 billion over five years.

The new funding for the NIH will go for projects like President Barack Obama’s “precision medicine” initiative that focuses on using a person’s genetic profile—or that of a tumor—to tailor a patient’s treatment. It also includes a project to amass genomic information on more than one million U.S. volunteers, assembling a database designed to home in on genetic mutations responsible for disease.

It drew some criticism from researchers and public-health advocates who argued it would weaken FDA standards for approving new drugs and devices. And some conservative Republicans were concerned about the amount of money for the NIH. Rep. Dave Brat (R., Va.) proposed an amendment that would make the spending discretionary and not mandatory. But that amendment was defeated, 281-141.

Sen. Lamar Alexander (R., Tenn.), chairman of the Senate Health, Education, Labor and Pensions Committee, has said he hopes to get parallel legislation through his committee by the end of the year and bring it to the Senate floor next year.

The House bill contains provisions favored by the drug industry regarding new-product approvals at the FDA. AdvaMed, representing the medical-device industry, said it also supports the bill, which it said “will increase the efficiency, predictability and transparency” of the FDA approval process.

The bill generally attempts to speed up FDA approvals of new drugs. Among other things, it would require the FDA to consider doctors’ clinical experience of a drug instead of just using randomized clinical trials. It also would encourage the FDA to rely more on things like biomarkers—early proxies of disease in the blood—instead of longer-term trials to assess effectiveness of drugs and devices.

Diana Zuckerman, president of the National Center for Health Research, and Thomas J. Moore, senior scientist at the Institute for Safe Medication Practices, wrote in an analysis that the bill “lowers the standards for the scientific evidence” used by the FDA to approve even high-risk medical devices. The bill, they wrote, would allow use of “anecdotal cases” and published studies to approve medical devices instead of clinical trial data.

In a recent article in the New England Journal of Medicine, Harvard Medical School doctors Jerry Avorn and Aaron S. Kesselheim wrote that certain provisions “could lead to the approval of drugs and devices that are less safe or effective than existing criteria would permit.”

July 10, 2015 12:07 p.m. ET

Write to Thomas M. Burton at [email protected]

Source: Wall Street Journal Health