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Cures Bill's Next Steps: W&M, Approps, Rules Panel Discussions; Late June Floor Vote

House Ways and Means is the next step for the 21st Century Cures Bill, which will also need to be discussed by the Appropriations, Budget and Rules committees prior to an envisioned House floor vote in late June, Energy & Commerce Chair Fred Upton (R-MI) said at a briefing after his committee unanimously passed the bill Thursday (May 21).

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A bipartisan bill was introduced in the Senate to give six more months without generic competition to drugs already on the market in return for approvals for rare diseases, just as a similar measure was approved the same day by a House committee as part of 21st Century Cures legislation.

CMS proposed funding Florida's Low Income Pool program at around $1.6 billion in state and federal money through June 30, 2017, in a new show of flexibility as the agency faces a lawsuit over the uncompensated care money and Florida nears its budget deadline for next fiscal year.

Sens. Kelly Ayotte (R-NH) and Cory Gardner (R-CO) introduced a bill Thursday (May 21) that would encourage manufacturers of “routine-use” contraceptives, such as birth control pills, to apply to the FDA to sell their products over-the-counter (OTC).

FDA in new draft guidance invites device makers to voluntarily submit scientifically valid patient preference data along with premarket approval applications (PMAs), humanitarian device exemption applications and de novo requests for use by the agency in benefit-risk assessments, and the agency says such information could make its way onto device labels.

Sources say the insurance industry's leading lobby will seek a high-powered replacement to long-time CEO Karen Ignagni, who has resigned from America's Health Insurance Plans (AHIP) in order to take the top job at EmblemHealth in New York starting Sept. 1.

State regulators this week called for insurers to adhere to higher security standards and increase awareness of cyber threats to better protect their customers, on the heels of a newly discovered breach at CareFirst BlueCross BlueShield that could affect up to 1.1 million people.

Senators Orrin Hatch (R-UT) and Martin Heinrich (D-NM) want the Department of Justice to step in and bolster what they view as FDA's limited ability to pursue individuals and companies manufacturing “dietary supplements” containing illegal products including anabolic steroids and active pharmaceutical ingredients (APIs). But industry sources question if FDA has the resources necessary to support DOJ criminal investigations.

Safety net hospitals and some lawmakers are pleased the House Energy & Commerce Committee opted not to include 340B reforms in its 21st Century Cures bill after some hospitals said changes to the drug discount program would have been a rushed addition to the legislation. Both industry stakeholders and lawmakers signaled they hope to continue discussions on the issue.