Congress has not passed a bill to revoke the FDA’s approval of a medication that was deemed safe for humans. The FDA’s authority to approve and regulate drugs is generally respected by Congress, and there is no precedent for legislative action directly overturning an FDA safety determination.

FDA’s Drug Approval Authority

The FDA’s role in approving drugs is well-established and protected by federal law. Congress has historically granted the FDA broad authority to regulate drugs and determine their safety and efficacy. This authority is typically not challenged through direct legislative action to overturn specific drug approvals.

Congressional Oversight and Influence

While Congress does not typically revoke FDA drug approvals directly, it does have ways to influence FDA actions:

1. Legislative Changes: Congress can pass laws that modify FDA’s regulatory framework or processes3.

2. Oversight Hearings: Congressional committees can hold hearings to scrutinize FDA decisions and potentially influence future actions6.

3. Budget Control: Congress can affect FDA operations through its control of the agency’s budget.

Recent Developments and Controversies

The issue of FDA drug approvals has recently come under scrutiny in relation to specific medications:

1. Mifepristone Case: In 2023, a federal judge in Texas attempted to suspend the FDA’s approval of mifepristone, an abortion medication. This decision was unprecedented and highly controversial, as it marked the first time a court had attempted to revoke approval of a drug the FDA had deemed safe25.

2. Right to Try Legislation: In 2018, Congress passed and the President signed a “Right to Try” law that allows terminally ill patients to access experimental treatments without FDA oversight. While this doesn’t revoke FDA approvals, it does create a pathway around FDA’s usual regulatory process in specific circumstances4.

3. Laboratory Developed Tests: In 2024, some members of Congress introduced a resolution to repeal an FDA rule regarding laboratory developed tests, showing that while Congress doesn’t typically revoke drug approvals, it may act to limit FDA’s regulatory reach in certain areas6.

In conclusion, while Congress has the theoretical power to pass legislation revoking an FDA drug approval, there is no historical precedent for such an action. The recent judicial attempt to revoke mifepristone’s approval was highly unusual and controversial, highlighting the established norm of respecting FDA’s scientific determinations on drug safety and efficacy58.

Based on the information provided in the search results, here is a list of DEA Schedule I substances:

Opioids

• Heroin

• Acetyl-alpha-methylfentanyl

• Acetylfentanyl

• Acryl fentanyl

• AH-7921

• Alpha-methylfentanyl

• Beta-hydroxyfentanyl

• Butyryl Fentanyl

• Furanyl fentanyl

• Isobutrylfentanyl

• 3-Methylfentanyl

Hallucinogens

• LSD (Lysergic acid diethylamide)

• Peyote

• Psilocybin (“magic mushrooms”)

• MDMA (3,4-methylenedioxymethamphetamine or “ecstasy”)

• Mescaline

Cannabis and Cannabinoids

• Marijuana (cannabis, THC)

• Synthetic marijuana and analogs (Spice, K2)

Other Substances

• GHB (gamma-hydroxybutyric acid)

• Methaqualone (Quaalude)

• Khat (Cathinone, Cathine)

• Bath Salts (3,4-methylenedioxypyrovalerone or MDPV)

Opium Derivatives

• Acetorphine

• Desomorphine

• Etorphine (except hydrochloride salt)

It’s important to note that this list is not exhaustive, as Schedule I contains numerous other substances135. The DEA classifies these drugs as having no currently accepted medical use in the United States, a high potential for abuse, and a lack of accepted safety for use under medical supervision136.