Support And Value Expectant Moms and Babies Act of 2023 or the SAVE Moms and Babies Act of 2023 This bill prohibits the Food and Drug Administration (FDA) from approving any new drug (either as a brand-name drug or a generic) intended to terminate a pregnancy and imposes additional restrictions on such drugs that are already approved. Under the bill, an already-approved drug intended to terminate a pregnancy may be dispensed to a patient only with a prescription. Furthermore, the FDA may not approve any labeling change that would authorize (1) using the drug after 70 days of gestation, or (2) dispensing the drug by any means other than in-person administration by the prescribing health care practitioner. The FDA must also impose additional restrictions on such already-approved drugs, including by (1) requiring the prescribing health care practitioner to receive a special certification, (2) prohibiting the practitioner from also acting as the dispensing pharmacist, and (3) requiring the practitioner to have the ability to provide surgical intervention to the patient. The bill also rescinds any investigational use exemption already granted to such a drug if the bill would have prohibited the FDA from granting the exemption. (Currently, the FDA may grant an exemption to certain market approval requirements if a drug is intended solely for use in safety and effectiveness investigations.)
Prescription Freedom Act of 2023 This bill generally eliminates the authority of the Food and Drug Administration (FDA) to require that a drug be dispensed only with a prescription. However, the FDA may continue to require a prescription for any drug intended for terminating a pregnancy.
Fairness in Orphan Drug Exclusivity Act This bill limits which orphan drugs may be granted a market exclusivity period by the Food and Drug Administration (FDA). (Generally, an orphan drug is one that is not economically viable because of the rarity of the disease that it treats; the sponsor of an FDA-designated orphan drug may be granted various incentives, such as a seven-year period in which the FDA may not grant market approval to a different sponsor for the same drug to treat the same disease.) Under this bill, if a drug is designated as an orphan drug on the basis that there is no reasonable expectation that the sponsor will recover the costs of developing and distributing the drug from U.S. sales, the drug shall be granted the seven-year exclusivity period only if the sponsor demonstrates that there is no reasonable expectation that it will recover such costs within its first 12 years of U.S. sales of the drug. When deciding whether an orphan drug meets this requirement, the FDA shall consider the sales of all drugs from the sponsor that are covered by the same orphan drug designation.
Healthy Technology Act of 2023 This bill establishes that artificial intelligence (AI) or machine learning technology may be eligible to prescribe drugs. Currently, certain drugs may be dispensed only upon a prescription provided by a practitioner licensed by law to administer the drug. Under this bill, an AI or machine learning technology may qualify as such a prescribing practitioner if the technology is (1) authorized by state law to prescribe the drug involved; and (2) approved, cleared, or authorized under certain federal provisions pertaining to medical devices and products.
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.
A bill to require the Secretary of Health and Human Services to prepare a report that outlines a plan for completing a review of approved opioid analgesic drugs that considers the public health effects of such opioid drugs.
Expressing the sense of the House of Representatives that the Food and Drug Administration has the authority to approve drugs for abortion care.
Prompt Approval of Safe Generic Drugs Act
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.
Protecting Life from Chemical Abortions Act This bill nullifies certain changes made by the Food and Drug Administration (FDA) to dispensing requirements for mifepristone. (Mifepristone is a drug that is approved to end pregnancies through 10 weeks gestation when used in conjunction with the drug misoprostol. The procedure is often referred to as medication abortion or the abortion pill.) The FDA regulates the use of mifepristone through the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) program. The program requires health care providers to comply with certain requirements in order to prescribe or dispense mifepristone to end a pregnancy; the program previously included an in-person dispensing requirement that required mifepristone to be directly dispensed to patients in clinics, medical offices, or hospitals. During the COVID-19 public health emergency, the FDA temporarily stopped enforcing the in-person dispensing requirement, which allowed mail-order pharmacies to fill and dispense mifepristone prescriptions. In January 2023, the FDA modified program requirements so as to (1) remove the in-person dispensing requirement, and (2) require pharmacies to be certified in the program in order to dispense mifepristone. The modifications allow retail pharmacies, after receiving certification, to dispense mifepristone pursuant to prescriptions that are written by program-certified prescribers. The bill nullifies the January 2023 changes and prohibits the FDA from (1) exercising any enforcement discretion with respect to program requirements, or (2) reducing program protections until every state submits certain data regarding abortions to the Centers for Disease Control and Prevention. The bill also generally prohibits the declaration of a public health emergency with respect to abortions.