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House overwhelmingly passes bill to speed FDA drug approvals

US Congressman Fred Upton, R-Michigan, has spearheaded the legislative push for the “21st Century Cures  Act.”
US Congressman Fred Upton, R-Michigan, has spearheaded the legislative push for the “21st Century Cures Act.”(Associated Press/file 2011)

WASHINGTON — A bipartisan bill that would make significant changes to the process for developing new drugs and medical devices overwhelmingly passed the House in a 344-to-77 vote Friday.

The bill, called 21st Century Cures, was cheered by rare across-the-aisle support from politicians, with 230 cosponsors nearly evenly split between Democrats and Republicans. The pharmaceutical industry, patient advocacy groups, and medical organizations also support the bill, which calls for an additional $8.75 billion for the National Institutes of Health.

‘‘This bill is about making sure our laws, regulations, and resources keep pace with scientific advances,’’ House Energy and Commerce Committee chairman Fred Upton, Republican of Michigan, said in a statement.

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The bill tries to address the impatience that stems from a major societal problem: despite billions of dollars of research into diseases that range from common cancers to the rarest genetic illnesses, treatments for thousands of conditions are still lacking. Many of its provisions seek to make the drug approval process less burdensome.

But its laundry list of provisions that tweak the process for approving new drugs or devices have raised significant concern from industry watchdogs and physicians who say the legislation is aimed more at helping drug and device companies than patients. Critics say the bill’s regulatory alterations do not address the real problem with the development of new therapies and could lead to the approval of treatments that don’t work and could even harm vulnerable sick people.

‘‘The bill unfortunately offers a horse trade,’’ said Vijay Das, a health care policy advocate at Public Citizen, a patient advocacy organization. ‘‘It increases funding for the world-renowned NIH in exchange for providing perks for the pharmaceutical and medical device industries.’’

The White House issued a statement that welcomed the additional support for biomedical research, but flagged the part of the bill that would extend a company’s exclusive right to market an already approved drug if it is repurposed to treat an orphan disease.

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The passage of the bill brings hope, however, to many people who have watched desperately ill family members struggle with devastating diseases that may have no effective treatments or cures.

Sarah Kennedy intently watched television in Mattawan, Mich., as the House took its vote. Her experience as a parent illustrates the powerful emotional pull of the bill. Her daughters, Brielle, 7, and Brooke, 6, suffer from spinal muscular atrophy, a genetic disease that attacks the nerve cells behind voluntary movements. The disease has no cure and eventually robs children of the ability to walk, eat, and breathe.

In their quest to find ways to give their daughters extra strength and more time, the Kennedys are willing to accept far more risk than if they were simply trying to treat an ordinary disease of childhood.

While these types of patient experiences are powerful, medical professionals worry that such arguments will be used to erode a carefully wrought standard of evidence that today helps to avoid the tragedies of the past, such as the birth defects caused by thalidomide in the 1960s and infertility caused by the Dalkon intrauterine device in the 1970s.