Two Republican members of the U.S. House of Representatives introduced legislation on August 27 that would grant newly approved botanical drugs a 12-year market exclusivity period, during which the FDA would be prohibited from approving generic or hybrid applications referencing those drugs.
House bill proposes 12-year exclusivity period for botanical drugs to attract private investment
Two Republican members of the U.S. House of Representatives introduced legislation on August 27 that would grant newly approved botanical drugs a 12-year market exclusivity period, during which the FDA would be prohibited from approving generic or hybrid applications referencing those drugs.
The Advancing Botanical Drug Development Act of 2026, designated H.R. 10150, was introduced by Reps. Lauren Boebert (R-CO) and Derrick Van Orden (R-WI). The bill seeks to amend the Federal Food, Drug and Cosmetic Act and was referred to the House Committee on Energy and Commerce on August 27; as of publication, no hearing has been scheduled.
Supporters of the bill argue the extended exclusivity period is necessary to overcome scientific, manufacturing, and regulatory challenges that they say currently discourage private investment in botanical drugs under standard intellectual property laws. The bill notes that botanical drugs can contain multiple naturally occurring active constituents capable of acting on several biological pathways simultaneously, and it cites advances in computational biology and artificial intelligence as tools for identifying such multi-pathway formulations.
The FDA established a regulatory pathway for botanical drugs in 2004, according to Joel Stanley, CEO of AJNA Biosciences, who was interviewed about the bill. The legislation arrives as cannabis rescheduling efforts under the Trump administration move toward finalization and as several patented synthetic psychedelic compounds are positioned for potential FDA approval.
Resilient Pharmaceuticals, formerly known as Lykos Therapeutics, resubmitted a previously rejected New Drug Application for an MDMA-assisted therapy treatment last month, according to a report first published by Psychedelic Alpha. On September 8, Definium Therapeutics's patented LSD compound received a second breakthrough therapy designation following the release of Phase III clinical trial data evaluating the drug for general anxiety disorder, the source states.
Robert Houton, founder of Mobilizing Accountability in Congress, said in an emailed statement that he helped initiate the legislative effort and is continuing to work with congressional leaders to introduce a companion bill in the U.S. Senate.
- The source does not state the position of the House Committee on Energy and Commerce regarding the bill.
- The source does not include any response or statement from the FDA regarding H.R. 10150.
- The source does not identify any opposing lawmakers, industry groups, or critics of the bill.
- The source does not specify which recent data Stanley cited when stating that a plant extract surpassed the efficacy of multiple FDA-approved drugs, nor name the study or reporting body.
- The source does not state what specific breakthrough therapy designation Definium Therapeutics's LSD compound received on September 8, nor name the agency that granted it — the sentence in the source appears to omit the agency name.
- The source does not describe the current standard exclusivity period for botanical drugs under existing law, making the proposed 12-year period difficult to contextualize.
- The source text supplied appears truncated; some material may be missing.
Read the original at Marijuana Moment