The FDA completed a draft guidance that would allow drugmakers to avoid paying rebates to pharmacy benefit managers and payers, according to BioCentury.
The creation of the legal loophole is included in the FDA's guidance on drug importation. The FDA said the guidance is intended to allow drugmakers to sell imported products at lower net prices that aren't inflated due to rebate payments.
If the guidance is approved, it could enable drugmakers to create a separate but parallel market that would be for imported drugs that could be sold at lower list prices to uninsured patients or those with large deductibles.
Under the proposal, drugmakers would be allowed to receive new National Drug Codes for imported drugs. Drugmakers also would be required to make sure the imported drugs are identical to those produced for the U.S. market, according to BioCentury.
In addition, the guidance proposes allowing drugmakers to avoid entering long-term contracts with payers and PBMs and also negotiate new contracts.
The proposal, which is currently under review by the Office of Management and Budget, will likely raise safety concerns regarding the potential for counterfeit or adulterated drugs. There could also be concerns that having identical products with different drug codes could interfere with the FDA's ability to track drugs.
It is also certain to face criticism, and possibly litigation, from PBMs and payers.
There is no deadline for the budget office to finish reviewing the proposal.
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