Iowa Senator Tom Harkin helped craft a huge bill that addresses the safety and availability of prescription drugs in America. Harkin is chairman of the Senate Health, Education, Pensions and Labor Committee.
“For almost 15 straight months we worked together, not in the glare of the spotlights, (but) behind the scenes working with the FDA, with the pharmaceutical companies, with the device manufacturers, with consumer groups (and) patient groups, to put together a consensus bill,” Harkin says.
The legislation provides the money for Food and Drug Administration programs that review new drugs and medical implants, like hip joints and pacemakers. For the first time, generic drugmakers will be required to pay a fee to the government for such reviews.
“In exchange for that, we’re going to have a speedier process for getting generics on the market,” Harkin says, “which is going to have an effect of keeping brand-name drugs down in price.”
The bill raises the maximum penalty for those caught making counterfeit drugs to $4 million, up significantly from the current maximum penalty of just $10,000. The bill gives the FDA authority to inspect foreign sites where the ingredients for many medications are now made and speeds up the process of approving drugs and antibiotics that will help treat life-threatening diseases.
“We’re going to have more personnel, better-trained personnel working for the FDA,” Harkin says. “They’re going to be able to approve things quicker — but still keeping in mind the primary goal of safety of patients — and we’re going to have better control over drugs and drug ingredients coming into this country from other countries.”
The bill passed congress this week and President Obama has signaled he will sign it into law.