Saturday, November 12, 2016

McConnell wants to pass bill to spur medical research before Congress adjourns; measure has big supporters and critics

Senate Majority Leader Mitch McConnell says he has two main priorities as Congress wraps up its business: funding the government and passing a bill called the 21st Century Cures Act, which would boost funding of research at the National Institutes of Health.

"You haven't heard much about it yet, but it's extremely important, McConnell said at his post-election news conference in Louisville. "We need to take advantage of today's technology to really jump-start the medical field."

McConnell said President Obama and Vice President Biden, who will leave office Jan. 20, want to get the bill passed because "The president's particularly interest in precision medicine," and Biden wants more cancer research because his son, Delaware Attorney General Beau Biden, died of cancer last year.

"I'm interested in regenerative medicine," McConnell said. "Unless you can get in a clinical trial, you can't get stem cells from your own body to treat another part of your body. He said he was motivated by the experience of a Tennessee man whose blindness was cured by stem-cell treatment.

The NIH budget has stagnated because of automatic budget cuts known as sequestration. A study published last year in Health Affairs concluded that most transformative drugs come from federally funded research, not from drug manufacturers, which cite research costs as a reason they need to make their higher profits than most other industries.

Still, makers of drugs and medical devices are strong supporters of the bill, because it would expedite regulatory approval of them new drugs and medical devices. That has drawn criticism from the industry's lobbying adversaries.

The consumer lobby Public Citizen says the House-passed bill would "undermine the FDA's ability to ensure the safety and efficacy of medical devices ... effectively lower FDA approval standards for antibiotics and antifungals ... weaken reporting requirements of the Physician Payment Sunshine Act, allowing for secret influence by pharmaceutical and medical-device companies ... hasten the rise of resistant superbugs by giving hospitals incentives to use new antibiotics rather than conserving them for appropriate use" and bar generic entry of medicines into the market for longer periods."

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