Posted 22 September 2015 | By Zachary Brennan

Democratic presidential candidates Hillary Clinton and Sen. Bernie Sanders are attempting to take on an issue the US Food and Drug Administration (FDA) can't control: rising drug prices. But some of their proposals would directly impact FDA authority.

On Tuesday, Clinton unveiled a plan that would decrease the market exclusivity for biologics from 12 years to seven years, require drugmakers to spend a minimum amount of money on research and development (R&D), bar pharmaceutical companies from deducting drug ad spending as a business expense and create a pre-clearance procedure via FDA to ensure drug ads provide clear information to consumers.

Under the proposal to lower the exclusivity period for biologics, Clinton also calls on the FDA to "give prioritized, expedited review to biosimilar applications that only have one or two competitors in the marketplace." She, like many others before her, is hoping the competition would inevitably lower the price of some of the most costly drugs on the market – biologics.

As far as other proposals that would help the FDA, Clinton calls on Congress to "fully fund the FDA’s Office of Generic Drugs to clear out their multi-year generic drug approval backlog, which has kept competitors off the market, and can help lower overall prescription drug prices.

"Prescription drug spending accelerated from 2.5 percent in 2013 to 12.6 percent in 2014," Clinton said in a statement. "It’s no wonder that almost three-quarters of Americans believe prescription drug costs are unreasonable."

Her plan, like others proposed by Democrats, also would allow Americans to import drugs from abroad, and she calls on FDA and other regulatory agencies to set "careful standards for re-importation" to ensure safety and quality.

Sanders Letter

Sanders, meanwhile, introduced legislation earlier this month that would allow Medicare to negotiate lower drug prices with pharmaceutical companies and let consumers import prescription medication from Canada.

He also sent a letter Monday evening to Martin Shkreli, CEO of Turing Pharmaceuticals, which hiked the price for the toxoplasmosis treatment Daraprim (pyrimethamine) by 5000% and sparked the clamoring for new ways to stop companies from hiking drug prices without justification. Sanders is specifically calling on Shkreli to provide more information on the price hike that could give him and Rep. Elijah Cummings an understanding of the underlying cause of the price increase.

Shkreli said in a number of interviews on Monday that the price increase is justified and provides the company with money that it will reinvest into R&D to find new treatments for toxoplasmosis.

Regulatory Loophole?

But what Shkreli did not discuss in any of the interviews Monday is the way that his company restricts access to generic versions of Daraprim via its distribution program.

FDA requires generic firms to conduct bioequivalence testing to demonstrate that a generic formulation is therapeutically equivalent to the brand drug. The testing requires the generic company to access a limited amount of the brand product, though some drugs are subject to distribution restrictions that can be used to prevent generic firms from obtaining such samples.

In some cases, the restricted distribution programs are implemented as part of FDA-mandated risk management programs, called Risk Evaluation and Mitigation Strategies (REMS), although when Congress authorized FDA to require REMS programs, it directed the agency not to use such programs to block or delay approval of generics.

The Federal Trade Commission last year filed an amicus brief in the U.S. District Court for the District of New Jersey explaining that the brand name drug manufacturer’s – in this case Celgene -- improper use of a restricted drug distribution program to impede generic competition could violate the antitrust laws.

"The regulatory framework for bringing old drugs into modern compliance has had unintended consequences, and it’s time to rethink it," chemist Derek Lowe added in a blog post on Monday.

Hillary Clinton Plan

Sanders Letter