Although Democratic presidential candidate Hillary Clinton's prescription plan was released almost a year ago, the former Secretary of State's intentions for dealing with the pharmaceutical industry were back in the news last week.
Although Democratic presidential candidate Hillary Clinton’s prescription plan was released almost a year ago, the former Secretary of State’s intentions for dealing with the pharmaceutical industry were back in the news last week in response to the significant price increase of Mylan’s EpiPen.
The new factsheet sheds light on her proposed strategy for combating situations like those generated by Mylan and Turing Pharmaceuticals, but it also rehashes some of her previously stated objectives to combat the larger problem of prescription drug spending in the United States. For pharmacists who may not have been paying close enough attention to the presidential race last September, this is a good opportunity to brush up on what the Democratic nominee has to say on this issue.
Although the issues with pyrimethamine and epinephrine have gotten the most press in recent months, Clinton’s factsheet highlights that pharmaceutical manufacturers have increased the price of “400 generic drugs by over 1000%” since 2008. To address this, Clinton has proposed that a consumer oversight board be established to monitor what she’s termed “unjustified, outlier price increases” by analyzing trends related to cost of production and patient value. Should the oversight committee identify an unreasonable price increase, the government would have the authority to step in and impose monetary penalties on manufacturers, which would go to support efforts to increase access and competition within the marketplace.
Realistically, such a dramatic policy shift may be quite difficult to achieve, as the authority to levy fines is something that must be given by Congress through legislative action. Given the current legislative, 2-party gridlock, moving legislation forward that would allow this to happen may be a slim prospect, but the fact that Clinton’s suggesting such a move should serve as a signal to pharmaceutical manufacturers regarding the attitudes of a Clinton administration towards potentially unethical price increases.
The one-two punch of fines and government support of competition wouldn’t be the only thing a Clinton administration would put in place to ward off dramatic price increases. Her plan also calls for emergency importation of “safe, high-quality alternatives…from developed countries with strong safety standards.”
This isn’t the first time Clinton has spoken favorably of the idea of drug importation. Her original plan stated that she’d “allow Americans to import drugs from abroad—with careful protections for safety and quality.” Elaborating on that strategy, Clinton’s website states that the FDA and other regulatory agencies would be involved in setting the standards for importation. Exactly what this would look like and the mechanisms to achieve such a goal, however, are matters that deserve some additional consideration.
An FDA guidance document from September 2015—shortly after Clinton’s original plan was released—allows for limited importation of unapproved substances for personal use with the goal of saving FDA resources, but also reiterates that foreign versions of chemicals approved for medicinal use in the United States “are often of unknown quality with inadequate directions for use and may pose a risk to the patient's health.”
It’d be interesting to see which, if any, foreign authority the FDA would deem as having sufficiently rigorous standards to allow them to be imported on a large scale. Such policy changes could have a particularly interesting effect were they to be applied to biosimilar markets that are significantly more developed in European countries than they are here. Given the FDA’s issues with generic drug approvals and desire to launch aggressive inspection campaigns on domestic compounding pharmacies, it’s also worth questioning how the FDA will muster up the resources to appropriately vet foreign firms wishing to compete here.
Price Negotiation and Other Efforts
Perhaps the most likely element of the Clinton plan to be enacted is the intention to allow the Centers for Medicare and Medicaid Services (CMS) to negotiate better prices directly with drug manufacturers. This is something we’ll likely see more on regardless of the outcome of the presidential race because Republican presidential candidate Donald Trump has also indicated intentions to give greater bargaining power to CMS. (Note that Trump has also indicated support for allowing less-expensive foreign pharmaceuticals to be sold here.)
Clinton has also expressed intention to increase accountability related to government-funded R&D for the pharmaceutical industry. These points strike at the heart of the debate of the prescription drug markets here. How well does it (and the health care system as a whole) respond to free-market principles? How do we as a nation appropriately incentivize companies to continue to invest in life-saving cures for serious illnesses?
Given some of the similarities between the Trump and Clinton platforms in terms of their plans for dealing with the pharmaceutical market, perhaps we should be pushing for the finer details regarding implementation of these policies as the clock continues to tick down to the November election.