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By Brian Broderick
Nov. 27 — A new law
aims to provide relief for drug companies seeking to market
prescription medications that are held up by slow Drug Enforcement
Administration decisions after they are approved by the FDA.
On Nov. 25, the White House announced that President Barack Obama signed H.R. 639. The measure establishes time limits for DEA actions on determining the proper category or schedule for drugs based on their potential for abuse.
Supporters say the measure will bring predictable
time frames to the DEA's scheduling process, which will allow
treatments to reach patients faster.
In March, bill sponsor Rep. Joe Pitts (R-Pa.)
described the time lag between Food and Drug Administration
approval of a new drug and the DEA's action on the drug, which is
necessary for certain medications to be marketed (51 DER 51,
3/17/15). Pitts' office said that under current rules, there is no
deadline for the DEA to make a scheduling decision.
The delays in DEA decisions increased in recent years, according to a statement from the lawmaker's office: In 1999, the average time between FDA approval and DEA's final scheduling was 49.3 days; by the end of 2013, the average approval time had risen to 237.6 days.
Earlier in November, when Congress sent the final
version of the bill to the president, Sen. Sheldon Whitehouse
(D-R.I.) said the legislation will amend the Controlled Substances
Act to require the DEA to schedule a drug or substance that has
never been marketed in the U.S. within 90 days of receiving a
scheduling recommendation from the secretary of the Department of
Health and Human Services (the FDA's parent agency).
Whitehouse's statement also said the legislation
clarifies that for the subset of drugs that must be scheduled,
market exclusivity periods begin on the date a product can actually
be marketed, just as it is for other new drug products. Whitehouse
is a sponsor of the Senate version of the legislation.
The lag time between FDA approval and the DEA's
decision on scheduling a drug, and the impact on when a company can
legally market a medication in the U.S., have been the subject of
litigation. Drugmaker Eisai sued the FDA to add back time to its
FDA-granted new drug exclusivity period for certain medications,
because of delays in DEA actions.
However, in September a federal district court ruled for the FDA, finding that the exclusivity period for a new drug begins when the FDA issues its letter approving the drug, even if the drug's manufacturer must await DEA's scheduling determination before it can bring the drug to market.
In addition, Whitehouse's statement noted that bill
will allow a company applying to register with the DEA to
manufacture a controlled substance to indicate on the application
that the substance will only be used for clinical trials of a
The name of the new law is the Improving Regulatory Transparency for New Medical Therapies Act.
To contact the reporter on this story: Brian Broderick in Washington at email@example.com
To contact the editor responsible for this story: Randy Kubetin at firstname.lastname@example.org
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