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Key Bills in the 2025 Legislative Session AAFP is Watching Closely

Alabama Academy of Family Physicians

HB 2 – Vaccine Consent What’s in the Bill: Sponsored by Rep. Under current law, minors aged 14 or older are permitted to consent to vaccines (excluding the Covid Vaccine) for themselves without parental consent. Here’s a brief overview of the key pieces of legislation that AAFP is diligently monitoring.

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A Reversal on Sequencing? Proposed Legislation Would Allow Patenting of Naturally Occurring Genes

FDA Law

Gibbs — A recent blog post focused on the potentially negative implications of the proposed Patent Eligibility Restoration Act (PERA) for manufacturers of generic drugs and biosimilar products. They argued that the legislation was necessary to spur innovation of new vaccines and therapies in response to emerging health threats.

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CMS Publishes Grab Bag of Proposed Changes to the Medicaid Drug Rebate Program

FDA Law

Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers. Price Transparency Surveys The MDRP statute requires manufacturers to submit only three prices: average manufacturer price (AMP), best price, and nominal prices.

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FDA-Approved Labeling: Is Enough Enough?

FDA Law

Specifically, the Court explained, because “[t]he Pregnancy Warning Regulation simply does not speak to whether a further warning related to a drug’s use during pregnancy can be added to the general Pregnancy Warning on a drug label, whether added by the FDA or added by a manufacturer,” the ”regulation does not, therefore, preempt state law.”

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A Review of H5N1

Alabama Academy of Family Physicians

There have been a few severe cases and one individual died with H5N1 infection. Also, CDC has provided a candidate vaccine virus to manufacturers for rapid production if needed. However, the 68 human cases in the U.S. It is important to note that no human-to-human transmission has been documented in any of the cases.

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COVID Updates: A Podcast with Peter Chin-Hong and Lona Mody

GeriPal

Our conversation covers: The current state of COVID Evidence for COVID boosters, who should get them, and preferences between Novavax and mRNA vaccines COVID treatments like Molnupiravir and Paxlovid Differences in COVID impact on nursing home residents and those with serious illnesses We wrap up with a “magic wand” question.

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Drug Pricing Reform Gathers Steam (Part 2)

FDA Law

The most far reaching drug pricing provision of Subtitle E is an amendment to the Social Security Act to establish a Fair Price Negotiation Program applicable to Medicare Parts B and D as well as group and individual health plans in the commercial market. the amount Part D plans pay pharmacies for the drugs).