The U.S. Supreme Court's eagerly awaited Affordable Care Act ruling unfortunately overshadowed the unusually bipartisan work underway at the U.S. Capitol last week, where Congress finalized sweeping legislation crammed with smaller-scale but still vital health reforms.
Among other things, the FDA Safety and Innovation Act will streamline medical-device approvals, help prevent shortages of lifesaving drugs and guard against dangerous new synthetic drugs -- measures championed by Sen. Amy Klobuchar and other members of Minnesota's congressional delegation.
Although a groundbreaking reform -- a new "track and trace" system to guard against the growing problem of counterfeit drugs -- was dropped from the final legislation, President Obama should move quickly to sign it.
Reforms in the legislation will benefit patients such as Axel Zirbes, a 5-year-old boy from Crystal, Minn., whose family was told that supplies of the leukemia drug he needed were running out.
Measures in the legislation also address key regulatory concerns raised by the medical-device industry, which employs an estimated 35,000 Minnesotans. In addition, the legislation will ban a frightening compound known as 2C-E and similar substances. A 19-year-old man died in 2011 after using 2C-E at the party in Blaine; other partygoers required hospitalization.
The legislation also will improve oversight of foreign drug manufacturers -- a win for all consumers.
A presidential signature is expected within the next week.
The massive legislation is known in Capitol shorthand as the "FDA user fee bill." As its name suggests, it's aimed at the Food and Drug Administration, the federal agency with broad regulatory authority over the drug and medical-device industries.
