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The Senate Parliamentarian on Friday ruled that key pieces of the Better Care Reconciliation Act (BCRA) -- including provisions implementing the six-month waiting period, restricting use of tax credits to buy abortion coverage and defunding Planned Parenthood -- violate the Budget Rules and must be removed from the legislation unless the decision is overturned by 60 votes.

A highly contested and yet-to-be-finalized rule on generic drug labeling has been moved from immediate priority to long-term priority on the White House Office of Management and Budget's road map for the year's upcoming regulations.

FDA is stopping work on several key rules including those regulating compounding, direct-to-consumer prescription drug advertising, child-focused tobacco sales, dietary supplement manufacturing practices and food safety testing, according to a list published Friday (July 21) by the White House Office of Management and Budget.

Conservative Sens. Ron Johnson (R-WI) and Mike Lee (R-UT) are circulating a positive HHS analysis of an amendment that would allow both ACA-compliant and non-compliant plans on the market, and Johnson says lawmakers may need to rely on HHS' findings instead of waiting for a Congressional Budget Office score should the amendment come up during Senate floor debate on health reform next week.

All of the former Congressional Budget Office directors on Friday (July 21) urged Congress to rely on CBO's analyses of legislation, coming two days after GOP senators said they will rely on a widely criticized HHS analysis of a key provision in the Senate GOP Better Care Reconciliation Act instead of waiting for CBO to score it.

FDA faces pressure from stakeholders to increase transparency around the citizen petition process, product hopping and other tactics used by brand makers to delay generic drugs from entering the market.

FDA faced pressure from a variety of stakeholders to take several specific steps to stop brand drug makers from using Risk Evaluation and Mitigation Strategies (REMS) to delay generic drug marketing -- but also faced push-back from the brand pharmaceutical and biologics lobbies to some of the ideas raised at a public meeting this week.

During an all-day public meeting on the Hatch-Waxman drug patent law and how FDA could help bring down drug prices by speeding generics to market, one presenter raised the idea of expanding the Bayh-Dole Act's march-in rights to cover any product regulated by FDA as a way to rein in prices -- an idea the agency noted “would be of interest.”

In addition to finding that the pending Senate health bill would result in 22 million more uninsured by 2026, the Congressional Budget Office said Thursday (July 20) that it would be impossible for issuers to design a benchmark plan by 2026 that complies with the legislation, since the $13,000 deductible needed to stay with a 58 percent actuarial value is more than the estimated maximum out-of-pocket costs for that year.