President Obama recently signed the Improving Regulatory Transparency for New Medical Therapies Act into law. The law clarifies when controlled substances are officially approved by the FDA, assisting with the calculation of exclusivity and patent terms. In addition, the law also establishes a new deadline for the DEA to schedule these substances, after they are approved by the FDA.
What is a controlled substance?
A controlled substance is defined as “a drug which has been declared by federal or state law to be illegal for sale or use, but may be dispensed under a physician’s prescription.” The federal government groups these substances into five categories based on “whether they have a currently accepted medical use in treatment in the United States, their relative abuse potential, and likelihood of causing dependence when abused.” The five categories are called “schedules” and are broken down as follows:
Regulation of Controlled Substances
In 1970 the Controlled Substance Act (CSA) was enacted, establishing a policy the regulation of certain narcotics, stimulants, depressants, hallucinogens, anabolic steroids, and a number of other chemicals. The CSA is implemented by the DEA, and is subject to change by the request of the FDA, HHS, DEA, or another party by submitting a petition to the DEA.
What is the Improving Regulatory Transparency for New Medical Therapies Act?
The new law states that if a drug has never been marketed in the US, the DEA has 90 days to schedule the drug after FDA approval has been granted. If the application is defective, the DEA is required to inform the applicant within ten days by providing a statement explaining why the application is not being accepted. In addition, the law states that the exclusivity period for controlled substances begins the day that the product is scheduled by DEA.
For more information on what the new law includes, view the full document here.
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