One of the most complicated steps in moving a drug from prescription to over-the-counter (OTC) availability is the creation of a medication label that can be easily understood by consumers so that they do not need the advice of a physician about whether, when and how to take the medication.

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The AMA praised a recent announcement by the Food and Drug Administration (FDA) that it has developed such a label for naloxone—the medication that can prevent opioid overdose deaths by reversing opioid-induced respiratory depression.

This new FDA action is likely to greatly facilitate the development of OTC proposals by manufacturers of the current naloxone products available by prescription. Although many states allow naloxone to be dispensed through a form of prescription known as "standing orders," OTC status would further increase access and save more lives that would otherwise be lost to opioid overdoses.

On Jan. 8, Rep. Mike Thompson (D-CA), chairman of the House Democratic Gun Violence Prevention Task Force, introduced the Bipartisan Background Checks Act of 2019 (H.R. 8), with a group of nine colleagues from both sides of the aisle. Jan. 8 also marked the eighth anniversary of the shooting in Tucson, Arizona, that killed six and wounded 13, including Rep. Gabrielle Giffords. Former Rep. Giffords, who now heads the group Giffords: Courage to Fight Gun Violence, was present at the bill's introduction. AMA has expressed support (PDF) for the bill.

Under current law, only federally licensed gun dealers must conduct background checks of firearms purchasers. Weapons sold at gun shows, on the internet or through other means are not subject to this requirement. H.R. 8 would close this loophole for almost all firearms transactions.

The bill has quickly garnered 221 cosponsors, more than the number of votes needed to pass the House. It is expected that the House will take up the bill in the coming weeks.

The FDA recently released an updated version of its Software Precertification Program working model (PDF), as well as a test plan (PDF) for the model for 2019. The Software Precertification Program, or "Pre-Cert" program, represents FDA's work to develop a new system for regulation and oversight of software functioning as a medical device, as the current regulatory structure for medical devices is not a good fit for the rapidly changing software marketplace. According to FDA's current thinking, the software Pre-Cert program will function as a "pre-check" program for software manufacturers, where manufacturers that receive a satisfactory determination after a corporate "excellence appraisal" would be eligible for streamlined review of their software products. Continued safety and efficacy would be ensured through post-market surveillance of those products.

The FDA plans to test the current version of the model in 2019 with volunteer participants that will assist in evaluating all aspects of the Pre-Cert program. The FDA anticipates that over the course of the test period, changes will be made to the program based on lessons learned, so the current working model does not represent a final or permanent regulatory pathway. The AMA has been working closely with FDA on development of this program to ensure that the program addresses concerns from the physician community.

On Jan. 14, the AMA submitted comments (PDF) on a proposed rule from the Centers for Medicare & Medicaid Services (CMS) on managed care in Medicaid and the Children's Health Insurance Program (CHIP). The proposed rule was published in the Federal Register on Nov. 14, 2018.

Substantial changes were made under the Obama Administration in 2016 to the regulation governing Medicaid managed care. CMS did not propose to replace the existing regulatory framework; rather the agency proposed revisions to the 2016 final rule, which included several provisions that went into effect for the plan year beginning July 1, 2018.

The AMA's comments focused on concerns that several significant provisions in the proposed rule could result in inadequate payments to physicians and other providers, weaken access protections for beneficiaries, especially through changes to network adequacy, and decrease information transparency. For more information on the AMA's comments, see the linked letter (PDF).

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