As part of the Democratic Party's new "Better Deal" economic agenda, lawmakers are going after the high cost of prescription drugs by proposing a new "price gouging enforcer." The enforcer would be confirmed by the U.S. Senate and direct a new agency designed to stop steep price increases such as the ones affecting anti-allergy medicine EpiPen in recent years.
But attorneys said the idea of a new prescription-drug czar may be a nonstarter. Private practice health care lawyers brought up issues of vagueness, chilling effects on innovation and increased costs, while questioning the effectiveness of the would-be program.
"It's a complete waste of time," Edward Allera, co-chair of Buchanan Ingersoll & Rooney's FDA and biotechnology section, said in his blunt assessment of the proposal. "You're going to create another bureaucracy for what? To tell people that drug pricing is too high? It's the worst possible solution. It won't go anywhere."
Republicans under the Trump administration have likewise expressed concern about soaring drug prices, though their efforts to address the problem so far have not included aggressively going after drugmakers. Rather, health care law experts say Republicans will likely attack the issue by trying to expedite approval of generic drugs, a task that would require the involvement of Congress and other U.S. Department of Health & Human Services agencies besides the U.S. Food and Drug Administration.
Howard Sklamberg, a former top FDA official who recently joined Akin Gump Strauss Hauer & Feld in Washington, D.C., said that would require a "multifaceted" approach.
The Democrats' three-page proposal released last week is light on details, including how the program would be funded, and heavy on statistics. It cites, as just one example, a CBS News report that prescription drug costs for the non-elderly are expected to jump nearly 12 percent in 2017, while wages would rise by just 2.5 percent.
It also names what it calls some of the "bad actors" in the pharmaceutical industry: Turing Pharmaceuticals, which increased the price of an anti-parasitic medication from $13.50 to $750 a pill overnight; and Valeant Pharmaceuticals International Inc., which in 2015 imposed massive price increases on two heart medications immediately after the company bought the drugs.
According to the proposal, the new prescription drug czar and his or her new agency would be responsible for protecting taxpayers and patients from these "egregious" increases by identifying drugs with "unconscionable" price hikes and imposing fines on the manufacturer proportional to the size of the price increase.