InstantGMP, Inc. Featured in PharmaTimes

Note: this article was written by InstantGMP, Inc.’s own, Kelly Waters, for publication in PharmaTimes and is available here.

This election cycle, there are two radically different candidates: the magnanimous tycoon Donald Trump representing the Republicans and the experienced former First Lady, former Senator, and former Secretary of State, Hillary Clinton representing the Democrats.

After each party’s respective national convention, the candidates released their full political platforms for this race. How do the candidates line up on pharmaceuticals and healthcare? 

Donald Trump (We’ve written about Trump’s plans for pharma before)

Trump has set his focus on restructuring the so-called “Obamacare” (the Patient Protection and Affordable Care Act), but not in all the ways people assume. While other Republicans talked about repealing Obamacare, Trump wants to focus on reducing the costs of prescription drugs for the American people through allowing drug reimportation and increasing the amount of generics available. 

Presently, drugs manufactured abroad are not permitted to be offered for sale in the United States. US citizens have been organising bus trips and shopping online for drugs in Canada and Mexico, and whereas it is technically illegal, officials “look the other way” for those with less than 3 month supplies of most drugs. Trump seeks to remove entry barriers for drugs produced internationally and would charge the Food and Drug Administration (FDA) with setting up an approvals process.

The FDA would also be directed to focus on clearing out the backlog of unapproved generic drugs so they can be approved for sale to the public. The thought is that citizens would closely pay attention to the quality of the drug for the price. As a result, drug companies will have to focus on efficacy and innovation to survive in the free-market.

Hillary Clinton (More about Clinton’s plans for pharma)

Clinton has made healthcare and reining in on the cost of prescription drugs the heart of her campaigns for decades. She made her first platform appearance in 1993 with the Clinton Health Care Plan of 1993 during President Bill Clinton’s first term in office. While the plan was widely criticised and failed, it encouraged Clinton to hone in her focus.

Like Trump, she plans to place more drugs on the market to increase competition, drive down prices and allow for Americans to shop around. Her plan differs in that Clinton cites the lack of oversight on pharmaceutical companies as the major cause of the inflated price of drugs.

Her plan would require manufacturers to reinvest a percentage of their revenues into additional research and development or else they will be ineligible to receive future federal funding. 

The most interesting aspect of her platform is her plan to regulate direct-to-consumer (DTC) marketing and advertising by pharma companies. A practice that is banned in many countries, Americans have seen a 60 percent increase in the frequency of drug commercials on television between 2012-2015. It is not uncommon to see a commercial for Cialis or Humira during daily watching, especially with sporting events. In 2015, drug companies spent $5.2 billion dollars in ads.

Clinton would charge the FDA with regulating these ads and requiring companies to pre-clear them before releasing them to the public to ensure that the risks and side-effects are clearly communicated.

Finally, she would decrease a drug’s exclusivity period from 12 years to 7 years; prioritise approvals for drugs and biologics with little-to-no competition; and allow drug reimportation for individuals.

Medicare

Both candidates also agree that Medicare should be allowed to negotiate special prices and foster cost-savings for the struggling social program.

Medicare Part D (also known as the Medicare prescription drug benefit) is a federal program that subsidises the costs of prescriptions and insurance premiums for Americans that receive Medicare benefits. Medicare Part D’s mission is to get necessary prescription drugs into the hands of those who are low-income, disabled, and/or senior citizens. 

Since Medicare was overhauled by the Medicare Modernisation Act of 2003 (MMA), candidates and legislators alike have attempted to require drug companies to offer different pricing to the program than what is offered the general public and average insurance companies.

Three provisions of legislation have been brought before Congress and all three provisions have either failed in receiving a majority or were unilaterally struck down.

Summary

Despite the media portrayal of a fiercely partisan election, both candidates want to focus on similar topics in the pharma industry. Both Clinton and Trump understand Americans’ struggles with affording medication and treatments that are necessary for survival or make a world of difference for patients. 

They also understand that in allowing for Medicare to negotiate drug prices, there are significant savings that can, in turn, be invested into other social programs or the expansion of Medicare itself. Both want to see healthcare providers be more transparent about actual costs and want to empower citizens to have more choices with more competitive options available on the market.

Where they differ lies with their plans to achieve these goals for the American public. Trump will enact reimportation with safety standards and Clinton will focus her attention on overhauling the drug industry as a whole by implementing a revenue-to-innovation ratio for companies that want to continue to receive subsidies, funding, and tax breaks.

This election will certainly have a major impact on the future of healthcare and pharma, perhaps to an extent that the United States and the world haven’t seen in a very long time.

Kelly L. Waters is Marketing Manager at InstantGMP. InstantGMP PRO is an electronic batch record software designed for Pharmaceuticals and Biotech that reinforces Good Manufacturing Practices (GMPs) required for regulatory compliance and the brain-child of Dr. Richard Soltero, former Director of Research and Development at GlaxoSmithBeecham.