The Trump administration issued numerous Executive Orders seeking to rein in drug prices. (See Recent and Possible Executive Orders on Drug Pricing: What You Need to Know – Government Contracts Navigator and Administration Issues Executive Order Tying Medicare Drug Costs to International Prices – Government Contracts Navigator.) While the Executive Orders made for good sound bites, none of them actually impacted drug prices. At the end of the day, most of the Trump administration initiatives never made it to the regulatory rulemaking phase, and those that did were met with legal challenges. Since then, in less than a month since taking office, the Biden administration has issued multiple Executive Orders and memoranda reversing the Trump-era Executive Orders and freezing pending regulations and enforcement policies with respect to existing regulations. Beginning on its first day, the Biden administration took action impacting drug prices and potentially signaled, directly or indirectly, the polices we may see over the next four years. The new administration’s actions have continued at a rapid pace. Continue reading “Biden Administration Already Impacting Drug Prices”
On July 31, the Department of Health and Human Services (“HHS”) and the Food and Drug Administration (“FDA”) announced their latest plan to reduce the prices Americans pay for prescription drugs. The Safe Importation Action Plan identifies two pathways for the importation of drugs.
Pathway 1 allows states, wholesalers, and pharmacists to submit plans to HHS for demonstration projects, which test and measure the effect of potential program changes, that allow for the importation of certain drugs from Canada. Importing drugs from Canada is not a new concept. In 2003, Congress gave the Secretary of HHS the authority to permit drug importation from Canada. To implement a drug importation plan, however, the Secretary was required to certify to Congress that the importation program poses “no additional risk to public health and safety” and the program will result in a “significant” reduction in costs of products to American consumers. No HHS Secretary has ever made such a certification to Congress. Implementation of importation plans under Pathway 1 will most likely take considerable time. HHS intends to implement Pathway 1 through a formal Rulemaking process with Notice and Comment. Then, importation plans will need HHS approval before going “live.” Continue reading “Will HHS’s Safe Importation Action Plan Affect How the Federal Government Purchases Drugs?”