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Generic Competition Debate

Brand Companies Attempt To Parlay FDA’s Focus On Generics Into More Exclusivity

Brand drug companies and industry-supported patient advocacy groups are attempting to use FDA’s reexamination of the Hatch-Waxman drug patent framework to push for greater exclusivity protections, which would further delay potential generic competition.

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House Republicans on Wednesday (Dec. 13) added the CHIP bill they already passed, including partisan offsets, to a must-pass bill to fund the government until Jan. 19.

Representatives of the drug-distribution sectors argued over the causes of drug prices at a House Energy & Commerce health subcommittee hearing Wednesday (Dec. 13), but lawmakers were left with unanswered questions and committee Chair Greg Walden (R-OR) said the subcommittee will likely hold another hearing on drug prices early next year.

A bipartisan group of six senators recently urged the upper chamber's leadership to include a provision to prevent a cut to hospital reimbursement for 340B drugs in an end-of-the-year package -- though it is unclear what legislation lawmakers may look to pass once the current continuing resolution runs out Dec. 22.

Sen. Rand Paul (R-KY) on Tuesday (Dec. 12) proposed letting drug companies offer varying up-front discounts because doing so would move industry away from rebates that are blamed for obscuring business deals many lobbyists and policy analysts say contribute to price increases.

Maine Gov. Paul LePage (R) on Monday (Dec. 11) sent the state legislature a list of demands he says must be met before the state expands Medicaid, as called for by Mainers in the Nov. 7 election.

Clinical laboratories on Monday (Dec. 11) sued the government over the fee schedule for tests.

FDA approved Monday (Dec. 11) the first fast-acting insulin to go through the abbreviated 505(b)(2) pathway, Sanofi-Aventis U.S.'s Admelog, a follow on to Lilly's blockbuster Humalog.

Brand drug makers on Friday (Dec. 8) challenged the constitutionality of a California drug-price transparency law.

Congressional Medicare advisers outlined a potential post-acute care pay system that CMS could use until a unified system is put into place.