fbpx Skip to main content

Public Policy Newsletter Article

2020 Federal Year-In-Review

  • 2020-12-03T16:00:00.000+0000
  • Author: Laure Fabrega

Biocom’s 2020 federal advocacy activities were in many ways defined by the covid-19 pandemic, which not only dictated reactive policies from both the Administration and Congress but also dramatically changed the working environment and priorities for the life science industry.

At Biocom, we have been committed to providing the resources necessary to help our members develop new vaccines, therapeutics, diagnostics, and medical technologies to fight the pandemic while also ensuring that members could continue to research and develop products for all the other diseases that didn’t stop affecting patients. Throughout the year, we provided countless updates on new legislative and regulatory orders and partnered with regulatory agencies to provide timely information to our members, such as the Food and Drug Administration (FDA) on conducting clinical trials during the pandemic and the Small Business Administration (SBA) on applying for the Payment Protection Program (PPP) and Economic Injury Disaster Loans (EIDL).

We established priorities with our members, including ensuring that: life science companies can continue to work despite stay-at-home orders, there is a sufficient stockpile of critically-needed products, small companies can have access to Paycheck Protection Program (PPP) funding, patients can have access to Medicare Part B infused drugs in a home setting, health plans don’t exclude cost-sharing assistance from counting toward patients’ annual out-of-pocket costs, the drug supply chain isn’t overhauled overnight, companies are incentivized to develop antibiotics, telehealth and remote patient monitoring services are expanded, temporary and targeted liability protections are in place, and visa processing for international researchers remains in place. We were successful on many fronts and are committed to working with Congress and the new Administration to ensure that all our priorities are included in covid relief or other legislative packages.

The pandemic didn’t stop the Administration from moving forward with proposals such as most-favored nation and importation, which Biocom had consistently opposed. We have communicated our opposition in the strongest terms to both the Administration and Congress, while continuing to educate about the value our industry brings to patients and the health care economy. We’ve also continued to advocate for the reauthorization of the rare pediatric disease priority review voucher program and increased funding for federal agencies through appropriation bills.

This year also marked the 40th anniversary of the Bayh-Dole Act of 1980, which has allowed research institutes and universities to pursue ownership of an invention derived from federally-funded research and license it to biotech companies. Prior to Bayh-Dole, many research projects were left on the government shelves and never reached patients. Throughout the year, we have communicated about the importance of Bayh-Dole and expressed strong opposition to “march-in” rights and compulsory licensing proposals that would hurt innovation.

Despite the pandemic, we have continued to engage Congress through legislative roundtables with Members of Congress, including Reps. Ami Bera, Scott Peters, and Harley Rouda, as well as educational webinars for congressional staff, including on America’s response to the covid-19 pandemic, Incentivizing research and development during a Pandemic, and the Use of Genomics in Response to the Pandemic webinar. We also formally created Biocom’s federal committee to guide Biocom’s federal policy agenda. The committee was connected to high-level congressional staff during our quarterly meetings, including Senate leadership, House leadership and Ways & Means. We also successfully hosted our rare disease advocacy fly-in, which allowed Biocom members to meet in person with many FDA and NIH officials, as well as members of Congress and staff.

Lastly, on the regulatory front, we submitted a myriad of comment letters to agencies to communicate our industry positions on issues important to our members, including on CMS’ Medicare Coverage of Innovative Technology (MCIT) proposed rule, CMS’ 2021 Physician Fee Schedule (PFS) proposed rule, CMS’ value-based purchasing and copay accumulator notice of proposed rulemaking, FDA’s Interpreting Gene Therapy Sameness draft guidance, CMS’ 2021 Inpatient Prospective Payment Systems (IPPS) proposed rule, FDA’s Importation of Prescription Drugs notice of proposed rulemaking, and FDA’s Bridging for Combo Products draft guidance, in addition to many other joint comments we submitted throughout the year.