There are plenty of articles out there about how the pharmaceutical industry may be affected by Donald Trump’s presidency. The problem is that nobody exactly knows how things are going to pan out over the next few years. When it comes to health insurance, the price of drugs, and the quality of providers across the entire health sciences landscape, President Trump is still “educating” himself on the issues and what they mean for Americans.
Big pharma is generally hopeful about the future under the Trump administration, as the overall message seems to reflect a lot of red-tape-cutting, which could help American companies successfully do business in the U.S. and effectively compete overseas.
This guide analyzes how artificial intelligence – including machine learning – can be used by pharmaceutical and medical device companies to improve the clinical data review and cleansing process.
This appears to be great news, but once you peek under the hood of that message, you see that it’s a much more complicated issue. So, do we all just wait and see what happens, or is there something that we can do within healthcare and life sciences to better prepare for potential changes?
- Healthcare: President Trump won the election, in part, by campaigning to repeal Obamacare. The executive order to repeal Obamacare, which was signed by Trump, can be looked upon as a vision or mission statement. It is going to take time to make any concrete changes, especially when you trying to replace something that is already in place with something that works better.
- FDA Regulations: President Trump has announced a plan to overhaul the FDA in order to speed up the delivery of new drugs to market. In 2016, new drug approvals fell to a six-year low. Only 22 new prescription products were approved here in the U.S., compared to 81 in Europe. A large percentage of these U.S. drugs were considered for rare diseases, which carry high price tags and affect fewer than 200,000 Americans.
- Drug Prices: The current prices for drugs on the market are getting a lot of bad publicity. Martin Shkreli, the former CEO of Turing Pharmaceuticals, certainly helped to bring horrendous price increases to everyone’s attention. Some 20 states are also looking into generic drug price-fixing here in the U.S.
- Access to Specialty Drugs: It is a challenge to get health insurance that provides coverage for specialty drugs and biologics (where there is no generic substitute). This has affected many cancer patients who are looking for cutting-edge medications that could help put certain cancers in remission and prolong lives.
- Tax Evasion: U.S. companies continue to use tax inversions and other means to avoid paying high U.S. taxes.
- R&D Investments: Overall, spending on therapeutic drugs continues to rise here in the U.S.; 8.5% year-over-year growth in 2015. Specialty drugs continue to have double-digit growth, up 21.5% in 2015, and are becoming more of a focus for pharmas and biotechs covering treatments, such as hepatitis, autoimmune diseases, and oncology.
- Alternative Medicine: Naturopaths and the use of holistic treatments have become more popular in recent years. In January 2017, Massachusetts became the 20th state to sign legislation to license naturopaths. This may not seem like much, in terms of creating a dent in the sales of therapeutic drugs, but the combination of the increase in direct-to-consumer drug ads, along with the knowledge of enduring side effects, may be pushing more Americans to eat healthier and find ways to prevent diseases rather than treat the symptoms. It’s not just therapeutic drugs vs. vitamins anymore.
- Technology: Technology is now part of every aspect of drug development, healthcare, and even wellness. At first, it was just used operationally, such as the digitization of medical records. But digital and mobile technology has become the primary way in which healthcare and life sciences organizations are engaging with patients, providers, physicians, regulators, partners, and even their own employees. Think: mobile apps, social media, bring your own device (BYOD) to work, or even virtual reality. Genomic testing and fitness trackers alike are helping to collect vast amounts of data that can be mined to help understand, treat, and prevent diseases. And the Internet of Things (IoT) has potential beyond our wildest imaginations.
Given all of that, we simply can’t afford to wait to see what the Trump administration does and how it impacts healthcare and life sciences. Now is the time to be designing and implementing strategies for navigating the road ahead.
To explore some key issues and perspectives from industry executives that have the potential to significantly impact the life sciences industry in 2017 and beyond, download The State of the Life Sciences Industry, our most recent guide.