House Approves Upton 21st Century Cures Legislation | 94.9 WSJM-FM

On Friday, the House will begin voting on the bill. It now awaits movement on two fronts: the Senate, where similar legislation is under consideration, and, ultimately, the appropriations committees, which must take the directives of the bill and turn them into hard dollars.

It can take up to 15 years for a drug to move from the laboratory to the pharmacy shelf.

“That means that 85 percent of the ideas that are out there to cure diseases aren’t being funded”, the congressman said in an interview. “Everyone agrees that is unacceptable; we must do better”.

The bottom line is the federal government is going to spend more money as a result of this bill.

The House bill would improve funding to the National Institutes of Health by nearly $eight.

To expand patient access to experimental drugs, the bill will reform the current system for allowing people to get drugs on a “compassionate use” basis.

To encourage companies to develop new antibiotics, which are not as lucrative as other drugs, the bill would provide a financial bonus to hospitals for administering antibiotics approved under the FDA’s new, shortened timeline.

But many outside organizations see too many potential positives, and have thrown their support behind the bill.

“””(Congress says) it will benefit patients, but it was written primarily by pharmaceutical and device companies and reflects their desire to get medical products approved on the basis of skimpier evidence than the law now requires”, said the National Centers for Health Research, a non-profit think-tank organizing some opposition to the act.

Sarah MacDonald, executive vice president of the Massachusetts Biotechnology Council, said, “Making the approval process faster isn’t necessarily a bad thing”.

“If there’s a shortfall in drug development, it is mostly because the companies have lost their verve in their ability to discover new drugs”. “And I don’t think it is just the spending”. Newer analytical methods, said Forbes authors, would go a long way toward speeding up the regulatory process.

McMorris Rodgers spoke at a House Republican Leadership press conference about the 21st Century Cures Act. Currently, a third of all new drugs are approved based on a single pivotal study, with a median 760 patients per trial. The Obama administration is generally supportive of new NIH money, and the president included a $1 billion boost in his proposed budget for the next fiscal year.

In response to legislative and political pressure, the FDA has offered numerous concessions to industry and its lobbyists. Upton’s been working on the legislation for over a year, holding roundtable meetings with doctors, patient groups, and researchers to fine out what the U.S. can do to help speed up the approval process for new ways of fighting disease. Though all drugs are supposed to meet “appropriate standards” for safety and effectiveness, the standards for most drugs approved through expedited pathways are clearly lower, with smaller and shorter term studies than are otherwise required.