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Public Policy Newsletter Article

2019 Federal Policy Review

  • 2019-12-18T04:21:00.000+0000
  • Washington DC
  • Author: Laure Fabrega

In 2019, our life science industry remained under intense scrutiny from Congress and the Trump Administration. In the first quarter, we saw many hearings on drug pricing from several House and Senate Committees. In May, the House passed several bills including the CREATES Act, the BLOCKING Act, and pay for delay and orange and purple books legislation. In August, the Senate Finance Committee passed a sweeping drug pricing package with proposed changes to Medicare Part B and D, Medicaid and transparency policies.

Meanwhile, the Administration finalized its direct-to-consumer (DTC) advertising rule, which we had opposed. The rule was blocked by the U.S. District Court for the District of Columbia before it could be implemented. The Centers for Medicare and Medicaid Services (CMS) abandoned a provision that we had also opposed, which would have allowed Medicare Part D sponsors to exclude protected class drugs from formularies. Biocom had submitted comments opposing both policies here and here.

Drugs pricing efforts culminated in December when the House passed H.R.3, the Lower Drug Costs Now Act, legislation championed by House Speaker Nancy Pelosi. The bill imports foreign price controls and imposes severe penalties on American innovators. Unfortunately, the bill passed by a 230-192 vote, with no Democrats opposing the bill. Click here to view our press release condemning the vote. Although this is a major setback for our industry, the bill is not expected to advance in the Senate.

Biocom remained active in the drug pricing debate all year long, engaging with our members to find reasonable policies and educating congressional offices about the impact price controls and other proposals would have on California’s life science industry. We also published an op-ed expressing concerns with the Medicare Part D redesign provision in the Senate Finance Committee package and jointly commissioned a report to show the impact of H.R.3 on the research and development (R&D) pipeline.

On the other hand, our industry was victorious on several fronts. In June, the Pandemic and All Hazards Preparedness and Advancing Innovation Act of 2019 (PAHPA) was signed into law. Biocom had strongly advocated for the reauthorization of the legislation and worked with the bill’s sponsors. The bill will ensure the development and stockpiling of medical countermeasures vital to our nation’s safety and defense ensures.

Most recently in December, the House and Senate reached a spending agreement to fund federal agencies until the end of the fiscal year, averting a government shutdown before the current continuing resolution (CR) expires on December 20. The agreement includes the full repeal of the 2.3 percent medical excise device tax, which Biocom had been championing for almost a decade. This is a major victory for the medtech industry. The tax would have been reinstated on January 1, 2020. The legislation passed in the House this week and is expected to be approved by the Senate and signed into law by the President shortly after.

On trade, Biocom supported the Administration’s United States-Mexico-Canada Agreement (USMCA), which included 10 years of data exclusivities for biologics, bringing Canada and Mexico closer to our intellectual property standards. Unfortunately, the Administration just announced a deal with the Speaker of the House to remove this provision. Biocom was quick to respond and express our strong concerns. Click here to view our statement.

Last but not least, Biocom continued its mission to bring the life science community and congressional and agency leaders closer together. Our annual Advocacy Fly-In brought in a group of California companies to Washington DC to learn about our regulatory and legislative environments and educate DC officials about new advances and challenges in the connected health space. We also hosted our annual Life Science Capitol Hill reception, our other signature DC event, which drew in Members of Congress, congressional staff, and life science leaders. This year, we held three Congressional briefings to educate congressional staffers on the drug development process, safe opioid management, and precision medicine.

We also held many events in California to connect our members to elected and regulatory officials. Our roundtable series featured meetings with U.S. Patent and Trademark Office (USPTO) Director Andrei Iancu, Congressman Mike Levin (D-49), and Congressman Eric Swalwell (D-15). We also connected our startups to high-level regulatory officials at an FDA/USPTO workshop in the Bay area and an NIH grants workshop in Los Angeles County.