If you’ve been keeping up with Congress and the Trump Administration over the last month or so, then you know that drugs have been pushed to the forefront of just about everything healthcare related. On May 11, The Department of Health and Human Services (HHS) released their drug pricing blueprint, American Patients First, which coincided with a speech from the President about the ridiculously high cost of pharmaceuticals and what his administration plans to do about it.

To be honest, the speech and accompanying blueprint did not exactly live up to the hype and I was sorely disappointed. In the weeks leading up to the speech and blueprint, just about everyone was speculating that this would be a dramatic shakeup in the industry. But, in the days prior, a few media outlets began running stories that the Trump Administration was going soft on big pharma because their proposal does not include efforts to directly control drug prices through government intervention. They were right. The blueprint does include some modest proposals specific to drug pricing, such as having FDA evaluate requiring drug manufacturers to disclose costs in direct-to-consumer advertising, but most of it is just “rearranging the furniture” as Aaron likes to put it. Basically, the Administration is considering a bunch of proposals and seeking feedback from the public through a request for information but don’t expect any dramatic changes soon. Anything with real teeth is going to take time, but I do anticipate legislative action in the coming months coupled with regulatory action that may occur as early as next week. Just kidding - action has already been taken by CMS.  

On the Hill, Congress hasn’t been focused on drug prices, but in passage of another package to address the opioid epidemic. Congressional leaders are aiming to have something to the President’s desk prior to the August Congressional recess. The Senate has settled on their vehicle, Opioid Crisis Response Act of 2018, subject to slight modification as other committees advance their proposals. Across the Capitol, the House is still working to compile their 40+ bills into one legislative package with the Energy and Commerce and Ways and Means Committees leading the effort.

Lastly, the 340B Drug Pricing Program has also received some attention as part of the overall conversation on drug pricing. Congressional leaders and the Trump Administration are concerned about folks “gaming the system” for profit. The biggest policy issue raised by policymakers is that there is not a requirement in statute dictating that savings from the program must be passed through to low income patients. Some have questioned the integrity of the program because Health Resources and Services Administration (HRSA), the agency in charge of 340B, lacks the authority to issue formal guidance and properly oversee the program. Again, I wouldn’t be surprised if legislative or regulatory action is forthcoming as hinted in the drug pricing blueprint.