House overwhelmingly passes bill to speed FDA drug approvals

By Carolyn Johnson, The Washington Post
July 10, 2015


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

The bill, called 21st Century Cures, was cheered by rare across-the-aisle support from politicians, with 230 co-sponsors 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.

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 diseases, we still lack treatments for thousands of conditions. 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 healthcare 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.” […]

“We share Congress’ desire to increase funding for NIH, but there are dangerous parts of this bill that many members of Congress did not fully understand,” Diana Zuckerman, president of the National Center for Health Research, a nonprofit think tank, said in a statement. “As often happens, well-funded pharma lobbying was more effective than experts’ concerns about patient safety.”

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