Worries About 180-Day Exclusivity Reforms Persist As User Fee Bill Advances
FDA-crafted legislative text emerges that generic industry says could weaken the incentive, but so far no changes are in the draft House and Senate bills.
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Therapeutic Equivalence Evaluations Would Be Required For 505(b)(2) Drugs Under Senate User Fee Bill
The Senate HELP Committee added a therapeutic equivalence provision to the draft measure it floated two weeks ago. The bill introduced in the Senate still does not include provisions on clinical trial diversity or 180-day exclusivity.
Clinical trial diversity, FDA hiring authority, and inactive ingredient disclosure provisions all get slight modifications. The bill glides through committee, but not without some complaints about agency performance.
Two of the most prominent features of the House package are not addressed in the Senate measure, which predominantly focuses on cosmetics, dietary supplements and laboratory developed tests. The absence of competing proposals suggests a smooth conference process.