Sen. Amy Klobuchar
Kyndell Harkness, Star Tribune
LACK OF STANDARDS
"The United States lacks strong, uniform national standards for licensure of pharmaceutical wholesalers, and we lack a standard system for companies to keep track of our pharmaceuticals during distribution. There is currently no way to check whether an individual vial or bottle is authentic or counterfeit.''
Source: March 8 congressional testimony of ALLAN COUKELL, Pew Health Group's medical programs director
Editorial: Drug, device reform gets bipartisan push
- July 2, 2012 - 8:43 PM
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.
The bill's main mission: determining how much in user fees the industries will pay the FDA in the next five years to offset the cost of clearing new products for market. The industries will contribute about $6 billion through 2017. The funding is longstanding practice and is supposed to help the resource-strapped agency review new products in a timely fashion.
Klobuchar, Sen. Al Franken and Rep. Erik Paulsen worked to broaden the legislation's scope. The state's two Democratic senators, as well as Paulsen, a Republican, pushed for measures that will streamline the medical-device approval process.
One key improvement: allowing the FDA to call on a wider array of experts to review new devices. Klobuchar also championed provisions to ban certain synthetic drugs, and advocated for measures to require drug firms to give the FDA an early warning if there are product discontinuations, supply interruptions or other problems that could lead to prescription-drug shortages.
A key disappointment is that the final version of the bill did not contain a provision to identify and root out counterfeit prescription drugs. High-profile incidents involving stolen or counterfeit doses of insulin, the cancer drug Avastin and the attention-deficit drug Adderall illustrate the need to address this public health threat.
Technological improvements are needed across the pharmaceutical supply chain to quickly determine where fake or stolen drugs might be, before patients unwittingly take them. In the rush to move the bill before the Supreme Court health ruling, political leaders and industry and consumer advocates simply ran out of time to smooth out disagreements on a "track and trace" proposal that was in the legislation.
There's still interest in Congress in the proposal, and new tracking requirements looming in California should give industry impetus to support a national system instead of dealing with various state proposals.
This is an important new public health initiative. Congress missed a key opportunity but should find a way in the months ahead to make it happen.
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