Life Science Compliance Update

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February 01, 2018

State of the Union De-Briefing

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President Donald Trump gave his second State of the Union address this week, and while reactions to his speech were mixed, he mentioned several items of importance to the healthcare space.

Affordable Care Act

First, he noted the repeal of the individual mandate found in the Affordable Care Act, by noting, “We eliminated an especially cruel tax that fell mostly on Americans making less than $50,000 a year -- forcing them to pay tremendous penalties simply because they could not afford government-ordered health plans. We repealed the core of disastrous Obamacare -- the individual mandate is now gone.”

Interestingly to some of his most ardent fans, however, the President did not call for the repeal of the Affordable Care Act in its entirety. Therefore, it seems as though his focus on the ACA will be muted with respect to the rest of the ACA that is still in place, including the Medicaid expansion and other reforms.

Right to Try

President Trump also noted his belief in right to try laws, stating, “We also believe that patients with terminal conditions should have access to experimental treatments that could potentially save their lives. People who are terminally ill should not have to go from country to country to seek a cure -- I want to give them a chance right here at home. It is time for the Congress to give these wonderful Americans the ‘right to try.’”

Vice President Mike Pence has long held Right to Try as a priority of his, and Trump’s call on Congress to pass legislation comes amid stalled House legislation, which easily passed the Senate in August.

More than half of the states have laws that already exist to allow some patients access to experimental treatments and the Food and Drug Administration also hash a pathway that grants expedited access to treatment to patients with terminal illnesses; however, FDA Commissioner Scott Gottlieb has been reluctant to expand much past that.

Opioid Abuse

Many Senators and Congresspeople wore purple ribbons in an attempt to highlight the opioid crisis. President Trump addressed this hot-button issue as well, saying, “In 2016, we lost 64,000 Americans to drug overdoses: 174 deaths per day. Seven per hour. We must get much tougher on drug dealers and pushers if we are going to succeed in stopping this scourge. My Administration is committed to fighting the drug epidemic and helping get treatment for those in need.”

As we have previously written, President Trump has always placed a priority on resolving opioid abuse, including creating a Task Force to review the situation and craft a plan of action. However, he has yet to propose new funding to help states respond (one of the suggestions we often hear from Democrats).

Newly appointed Health and Human Services Alex Azar recently highlighted the administration’s five-point strategy, including (1) encompassing better treatment, prevention, and recovery services; (2) better targeting of overdose-reversing drugs; (3) better data on the epidemic; (4) better research on pain and addiction, and (5) better pain management. Funding for treatment will continue to be central to the debate, and it remains to be seen whether Congress will provide the boost that many public health advocates have been calling for.  

Drug Pricing

Prescription drug prices were a hot topic in the 2016 Presidential election and were, naturally, mentioned during the State of the Union as well. President Trump stated, “To speed access to breakthrough cures and affordable generic drugs, last year the FDA approved more new and generic drugs and medical devices than ever before in our history... One of my greatest priorities is to reduce the price of prescription drugs. In many other countries, these drugs cost far less than what we pay in the United States. That is why I have directed my Administration to make fixing the injustice of high drug prices one of our top priorities. Prices will come down.”

Given the political climate, little action has been seen on this front while excessive rhetoric continues to be the modus operandi of the political class.

Conclusion

Overall, there were statements by the President that earned cheers and some jeers from both sides of the political aisle. While lip service can be effective in providing a motivating speech, we will have to wait to see what changes are actually effectuated in the future.

 

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