A conservative, pro-business president who campaigned on reducing taxes, reducing regulations, improving U.S. trade policies and creating jobs. Sounds great for the life science industry. Right?
Not so fast.
At his January 31, 2017 meeting with pharmaceutical industry leaders, reviews were mixed. Right out of the gate, president Trump decreed the following:
- Drug prices are too high and that his goal will be too work to significantly reduce drug prices.
- The FDA review process must be “streamlined” in order to make life-saving medicines available to patients faster. He picked Scott Gottlieb to as the new FDA commissioner -- Mr. Gottlieb must still be confirmed by congress
- President Trump will insist on trade deals that require other countries to “pay their fair share” for drugs manufactured on the U.S.
Keep an eye out for mixed reactions and trends from key constituents:
- Will express caution over a streamlined FDA. They say a faster review process may put patients at risk, however, their caution is primarily tied to payers needs for robust data to justify reimbursement of high-cost new drug versus old formulary drugs.
- Big pharma will support price controls only in the context of reforming existing laws and regulations that are currently preventing private companies from negotiating better deals and paying for medicines based on the value.
- Big pharma will be worried that the Trump administration’s plans would increase competition on the market by cutting the patent life of drugs to speed up the pathway to generics.
- Biotech firms will be more supportive of streamlined FDA review processes, however will walk the line since they are all hoping to sell their drug candidates to big pharma in the future.
- Most legislators will not support a streamlined FDA, and will most likely divide along party lines regarding international trade policies.
- Washington never likes any threats designed to reduce the size and scope of its infrastructure
- Expect payers to flex their muscles for greater evidence of value, especially for new, premium-priced medicines.
- The failure of president Trump to overturn the Affordable Care Act will further strengthen the positon of health insurers creating yet another headwind for life science innovators.
- Watch for key patient advocates, especially rare disease groups, to support a streamlined FDA process.
- Patient advocates always support greater access and lower drug prices.