October 5, 2015

Prescription Affordability - Watching the Presidential Race:
While the American presidential elections are still more than a year in the future, it is interesting to consider how lively and bruising the combat has been so far.
Hilary Clinton, presumed by many to be the unchallengeable front-runner for the Democratic nomination, has seen the unexpected rise of Bernie Sanders as a competitor for the nomination, as well as a potential challenge for the nomination from the current vice president Joe Biden. As regards the race for the Republican nomination, the unpredictable and meteoric candidacy of Donald Trump has added a good deal of interest and intensity to the large and contentious field for the Republican nomination and to date, two candidates who were once widely regarded as serious contenders have dropped out. The lengthy process involved in both nominating candidates, as well as the actual election that follows, may yield even more surprises as candidates vie for attention from a fickle electorate. What is especially worth noting is that some of the issues raised during these campaigns can have a direct and profound impact on healthcare and Life Sciences.
This is not mere speculation. A quick review of history shows how important presidential politics and presidential action has been for issues which can have a direct effect on the life sciences industry. For instance, the Pure Food and Drug Act of 1906 was a key piece of Progressive Era legislation, supported and signed by President Theodore Roosevelt.
During the New Deal era, the FDA was expanded and Congress passed the Federal Food, Drug, and Cosmetic (FDC) Act of 1938. Although President Roosevelt’s role in these events wasn’t necessarily central, they occurred against the backdrop of a shift that Roosevelt was advocating at the time, to a more activist and involved government.
Some subsequent milestones also tie closely to the agenda of the occupant of the White House. For instance, The Fair Packaging and Labeling Act of 1966, one of the initiatives of President Johnson’s Great Society, required all consumer products, including OTC drugs, to have “true and informative labels”. Johnson also sought the involvement of the National Academy of Sciences and National Research Council in related efforts, in order to measure the effectiveness of 4,000 drugs which had been previously approved between 1938 and 1962 on the basis of safety alone.
More recently, President Obama made consumer healthcare coverage one of the centerpieces of his first administration and with Congress, was able to enact the Affordable Care Act, with all its substantial implications for Life Sciences.
The current cycle of presidential electioneering has already generated a detailed proposal for changing major aspects of the prescription drug market from Democrat Bernie Sanders. According to Sander’s web site, his plan includes six major policies such as enabling Medicare to more aggressively negotiate discounts, allowing prescription drug imports from Canada, eliminating the infamous “donut hole” in Medicare Part D, as well as implementing measures targeting anti-competitive behavior by drug makers.
While it is still very early along the road to November 2016, and Sanders is thought by many pundits to be unlikely to become his party’s standard bearer, Bernie Sander’s proposals are getting a certain amount of visibility and could be serve to influence the policies of other candidates in an effort to galvanize electoral support.
Sanders is far from alone in offering proposals of consequence for the healthcare and Life Sciences industries. For instance, fellow Democrat Hillary Clinton has suggested boosting benefits under the Affordable Care Act, including lower monthly caps on prescription drugs for patients with chronic or serious health conditions. She too would allow prescription drug imports from Canada. On the Republican side, many candidates have proclaimed their opposition to the Affordable Care Act, including Jeb Bush, retired neurosurgeon Ben Carson, former ophthalmologist Rand Paul, and Donald Trump. Each supports some kind of repeal or replacement for the law. Trump, in particular, has suggested “breaking the monopolies” of the insurance companies and returning to “free market principles.”
With such a wide spectrum of views on displays, everyone in the Life Sciences sector should be paying attention to the political discourse. Recognizing that healthcare issues touch nearly every voters, we as an industry should be ready to engage and inform the candidates and the public about the substance of these issues and any concerns that these issues raise, so an informed debate can occur.

Contributed by:

Lisa Keilty, Global VP of Compliance and Strategic Solutions, AHM

Lisa joined AHM after serving as founder of the Compliance Consulting firm PMC2 and spending over 26 years in the life sciences and meeting management industry. Leading such organizations as Pfizer, Bristol Myers Squibb and Biogen Idec through numerous international projects, financial transparency and reporting requirements, Lisa’s industry expertise has saved Life Sciences and Meeting Management organizations over 30 million dollars. As a member of the Business Development team, Lisa’s primary focus will be Thought Leadership,Demand Generation and Solution Design.