HEALTH CARE BRIEFING: Generic Manufacturers Prepare to Fight Exclusivity

HEALTH CARE BRIEFING: Biden's HHS to inherit legal battles

The generic drug industry is gearing up for a busy year as lawmakers reflect on changes in the pharmaceutical supply chain and drug pricing.

The Covid-19 pandemic has sparked fears among US regulators and lawmakers over drug shortages and the United States’ reliance on foreign drug producers, especially for essential ingredients in generic drugs.

“Much of the conversation, especially in early 2020, was about whether we are too dependent on one part of the world for manufacturing,” said Erik Komendant, vice president of federal affairs for the Association for Accessible Medicines. The group is the main lobbying organization for Pharmaceutical industries Teva, Novartis Sandoz and other manufacturers of generic drugs. “These concerns did not materialize because of our members.”

Generic makers will advocate this year to cap what seniors pay for Medicare drugs, and they will take the rising price of brand name drugs, according to industry watchers. They are also defending themselves against a push to change the 180 days of exclusivity granted to certain new generics. Generics have been targeted by lawmakers worried about companies abusing exclusivity rules and drug availability if global supply chains are disrupted.

Presentation of a bipartisan duo to the Chamber a bill at the 116th Congress which seeks to limit “parking” on a generic drug application – when a company blocks the competition. Pharmaceutical companies can get 180 days of exclusivity on a drug if they are the first to file a claim with the Food and Drug Administration. This bill was part of a bicameral deal on surprise billing and healthcare cost legislation, but it was not included in a year-end spending deal along with the rest of the measure.

AAM has increased its tab of lobbying over the past four years, even though it and individual drugmakers still spend far less than brand name companies and their lobbying organization, pharmaceutical research, and manufacturers in America. The AAM spent nearly $ 4 million in 2020, up from $ 3.5 million in 2017, but less than the $ 4.75 million paid in 2019, according to federal lobbying revelations.

Two of the largest generics companies, Teva and Viatris, spent $ 2.1 million and $ 2.3 million respectively in 2020. Teva’s spending decreased slightly from 2019, while Mylan, which merged with another company to become Viatris in 2020, paid $ 4 million in lobbying until 2019.

PhRMA saw a year of decline in 2020, spending $ 25.5 million on lobbying, federal disclosures show. Among the major brands, Amgen increased its spending to $ 11.1 million, from $ 8.5 million in 2019, while PfizerSpending of $ 10.9 million was little changed last year from the previous year. Learn more about Alex Ruoff.

Lobbying flourished in 2020 Bolstered by virus advocacy: The coronavirus pandemic has been a boon to Washington lobbying firms, many of which recorded record revenues in 2020. Lobby leaders predict this trend will continue this year with a flurry of activity from a new administration and Congress. Akin Gump Strauss Hauer & Feld, the # 1 company in terms of revenue, collected $ 49.6 million in lobbying fees last year, $ 7 million more than in 2019, which represents the highest revenue the company’s lobby store has ever recorded. Brian Pomper, co-director of public law practice and cabinet policy, expects work to continue with President Joe Biden trying to push forward an ambitious agenda through a tightly divided Congress. Learn more about Megan R. Wilson.

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