Senate Passes Bill to Extend Marketing Exclusivity Period

A measure that would extend the exclusivity period for branded new drugs cleared the Senate Oct. 26.

The measure, which the Senate passed by unanimous consent after amending it from an earlier House proposal, would change when new drugs are considered to have been approved, basing it on the date the Drug Enforcement Agency scheduled them, rather than when the FDA signs off on them. The Improving Regulatory Transparency for New Medical Therapies Act, H.R. 639, would allow drugs to be sold before the DEA assigns them to a controlled substance schedule.

The bill requires the DEA to issue an interim schedule for a controlled drug or biologic within 90 days of FDA approval or Health and Human Services’ scheduling recommendation, whichever comes later. The drug could be marketed immediately with the interim scheduling while it awaits a final decision.

Earlier in October, a federal judge dismissed a lawsuit against the FDA over when marketing exclusivity begins, agreeing with the FDA’s interpretation that exclusivity begins with NDA approval, and not the date of controlled substance scheduling.

The bill also extends exclusivity periods for a new drug by changing the date it is considered to have been approved from the current FDA sign-off to when the DEA schedules it for sale. Drugmakers have complained that they have lost exclusivity rights while waiting months in some cases for the DEA action.

The Senate revised the bill to include a section allowing the U.S. and members of the European Economic Area to allow exportation and re-exportation of drugs among member nations.

The bill returns to the House where sponsor Rep. Joseph R. Pitts (R-Pa.), said he will work to reconcile any differences.

The House approved the bill via voice vote in March. The White House did not say whether President Barack Obama would sign the legislation.

As of deadline, the House had not taken up the revised measure. — John Bechtel


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