Posted 17 March 2015
By Alexander Gaffney, RAC
The US House of Representatives has passed a new bill which promises to accelerate market access for new pharmaceutical products requiring review by the US Drug Enforcement Administration (DEA), and also changes the definition of what drug "approval" means for some new drug products.
The bill in question, the Improving Regulatory Transparency for New Medical Therapies Act, is meant to address a regulatory process some drug companies have described as a "black hole."
While a drug is required to be approved by the US Food and Drug Administration (FDA) in order to be marketed, the DEA must also sign off on drugs subject to the Controlled Substances Act (CSA).
The CSA, which provides for the scheduling of drugs into various classes of control, is meant to ensure that drugs that might be misused or abused aren't as readily available to consumers. For example, a drug subject to Schedule II controls might have restrictions on how many refills are available without a new prescription, and the quantity of product allowed to be prescribed at a single time.
The problem, as Focus has noted, is that DEA can take more than a year to schedule a product under the CSA, even when FDA has made specific recommendations regarding the drug’s scheduling. That delay leaves patients without access to an FDA-approved therapy and companies without the ability to market their drug.
The bill, as Regulatory Focus has previously explained, would require DEA to schedule drugs according to a strict timeline, giving drug manufacturers and patients more predictability. DEA would also be tasked with developing "interim" decisions, which would permit a drug to be marketed under an interim classification while a final decision was determined.
Read our previous coverage of the bill and its provisions here.
The legislation also makes it easier to provide drugs under a clinical trial. DEA would be required to review applications to manufacture a controlled substance (Schedule III, IV or V) for use in a clinical trial within 180 days of receiving the application, and Schedule I or II drugs within 180 days, not including a notice and comment period and a 90-day application window.
Bill Advances with a Major Change
On 16 March 2015, the House voted to approve the bill, sending it to the Senate for consideration.
The new iteration of the Improving Regulatory Transparency for New Medical Therapies Act is considerably longer than previous iterations, and borrows some ideas from a previously-introduced Senate bill, the Regulatory Transparency, Patient Access, and Effective Drug Enforcement Act.
One major and important change to the bill is that it redefines when a drug is "approved" under the law. Under current practice, a new drug's marketing exclusivity begins upon FDA's approval of a drug, even if that drug can't be marketed due to a lack of DEA scheduling. Under the latest iteration of the bill, a drug's marketing exclusivity begins when DEA allows the drug to be marketed, either conditionally or under a final rule.
In the US, marketing exclusivity generally gives products between three and 12 years of protection from generic competition.
The bill also provides for patent extensions—already granted to companies to help make up for some of the time lost during FDA's regulatory review process—to account for the time it takes DEA to review a drug for scheduling.
Interim scheduling decisions are supposed to take place within 90 days of FDA or the Department of Health and Human Services (DHHS) making a scheduling recommendation, the bill states.
The bill must now be approved by the Senate and President Barack Obama before it may become law.
Improving Regulatory Transparency for New Medical Therapies Act