Prompt Approval of Safe Generic Drugs ActThis bill authorizes the Food and Drug Administration (FDA) to approve certain applications to market a generic drug despite the omission of certain safety information from the generic drug's labeling.Specifically, the FDA may not deem an abbreviated application for approval of a generic drug ineligible for approval solely because the drug's labeling omits safety information that is protected under another drug's patent or exclusivity protections. Similarly, a drug that is approved under this bill may not be considered mislabeled for lacking such safety information.Generally, an abbreviated application, for the purposes of this bill, is one that (1) uses required information from studies not conducted by the applicant; or (2) seeks approval of a drug that is, for drug approval purposes, a duplicate of an already-approved drug (i.e., a generic drug). Currently, the labeling for such a generic drug must generally be identical to that of the already-approved drug. This bill provides an exception to that requirement under the specified circumstances. For any drug approved under this bill, the FDA must require the drug's labeling to include any safety information that is necessary to assure safe use.
Impact
The bill could significantly alter the landscape of drug approval and regulation by the FDA. By allowing drugs that lack certain safety information to be approved without facing misbranding issues, it aims to expedite access to potentially safe generic medications for consumers. This measure is expected to energize the market for generics, which may lead to more competition and, consequently, lower prices for consumers. Furthermore, it could potentially encourage pharmaceutical companies to file more applications for generic drugs that might have otherwise been deterred by stringent labeling requirements.
Summary
House Bill 843, known as the Prompt Approval of Safe Generic Drugs Act, seeks to amend the Federal Food, Drug, and Cosmetic Act with the goal of facilitating quicker approval processes for drugs whose safety information has been added to their labeling. Specifically, the bill would ensure that a drug is not deemed misbranded or ineligible for approval solely because certain safety information—such as contraindications, warnings, or precautions—has been omitted from its labeling, providing that this omission is protected by exclusivity or patent rights.
Contention
However, the bill has sparked debate regarding safety and efficacy. Critics express concern that enabling drug approvals without complete safety labeling could leave patients at risk if important safety information is not conveyed adequately. Opponents worry that the bill may erode FDA standards and oversight and potentially lead to the approval of drugs that could pose risks. These concerns underscore the tension between enhancing market access for generics and maintaining stringent public health safeguards.
Requires health plan coverage to include generic drugs and biosimilars where the wholesale acquisition cost of such generic drugs or biosimilars is lower than the brand drug's wholesale acquisition cost.
Mandating Exclusive Review of Individual Treatments (MERIT) Act This bill specifies that coverage determinations for drugs and biologics under Medicare must be made with respect to each drug or biologic, rather than with respect to a class of drugs or biologics.
To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes.
Patient Access to Urgent-Use Pharmacy Compounding Act of 2023 This bill relaxes certain requirements for compounding drugs that are facing shortages. Drug compounding is the process of mixing or otherwise altering drugs to create a medication. Currently, the Food and Drug Administration (FDA) allows for drug compounding subject to certain requirements. Generally, a licensed pharmacist or physician not registered with the FDA may only compound drugs in limited quantities for prescriptions for a specific individual patient. On the other hand, an FDA-registered outsourcing facility may compound drugs in bulk for use in medical facilities but is subject to additional requirements. This bill allows a compounder not registered with the FDA to compound drugs in limited quantities for an urgent medical need not involving a specific patient if, among other requirements (1) the prescriber certifies that the prescriber is unable, despite reasonable attempts, to obtain certain related drugs with the same active ingredient and route of administration; (2) the compounded drug meets certain labeling requirements, including an indication that the compounded drug is provided only for urgent administration to a patient; and (3) the compounder requests and maintains certain records about patients receiving the compounded drug. Furthermore, a restriction against an unregistered compounder regularly compounding (or compounding inordinate amounts of) what is essentially a copy of a commercially available drug shall not apply if the drug is on a shortage list maintained by the FDA or the American Society of Hospital Pharmacists.
Lower Drug Costs for Families Act This bill applies certain Medicare prescription drug rebate requirements to prescription drugs that are available under private health insurance. Current law requires drug manufacturers to issue rebates to the Centers for Medicare & Medicaid Services for brand-name drugs without generic equivalents under Medicare that (1) cost $100 or more per year per individual, and (2) for which prices increase faster than inflation. Manufacturers that fail to comply are subject to civil penalties. The bill applies these requirements to prescription drugs that are available in the commercial market under private health insurance. It also indexes rebate calculations to drug prices in 2016 (as opposed to 2021).