Premier on June 1 shared nine policy recommendations to boost drug competition, lower the cost of medications, close regulatory loopholes and prevent price hikes.
Here are the nine Premier policy recommendations.
- Accelerate the drug approval process. The Food and Drug Administration should be required to prioritize review of generic drug applications when three or fewer manufacturers develop the drug.
- Crack down on drugmakers abusing Risk Evaluation and Mitigation Strategy rules. Drugmakers often use the FDA's REMS program to deny generic drugmakers access to samples of their brand name drugs, which are needed for the drug approval process. Congress should prohibit drugmakers from limiting access to these brand name drugs.
- Prohibit pay-for-delay deals. Congress should outlaw anticompetitive deals where branded drugmakers pay generic companies to keep their medications off the market.
- Improve access to biosimilars. FDA should ensure biosimilars can be safely substituted for biologics to further increase market competition.
- Close the orphan drug loophole. Congress should scale back orphan drug status to new drugs only used for one small patient population, so drugmakers cannot take advantage of exclusivity periods and other incentives by expanding the drug to additional patient populations.
- Impose stricter rules on product evergreening. Drugmakers should be barred from seeking FDA approval for a new formulation of an existing drug just to extend the life of a patent.
- Limit abuse of citizen petitions. Drug companies can delay the launch of generic products by discreetly filing citizen petitions — intended for the general public or consumer groups to file — which the FDA must review before making a regulatory decision on the generic drug. To limit this abuse, drugmaker executives should be required to file the petition themselves, and companies should be subject to financial penalties for frivolous petitions.
- Ensure safe, older drugs are still available at low prices. The FDA currently requires competing drugmakers to leave the market when a new version of an older, grandfathered drug is approved. The FDA should allow drugmakers to stay in the market for 18 to 24 months after an approval to boost competition.
- Keep drug labeling consistent. The FDA proposed a rule that would put drugmakers in charge of labeling their products, which would produce different labels for equivalent drugs. As these differences could undermine generic prescribing, the FDA should continue to serve as the central authority for drug labeling to ensure labels remain uniform.
To view the full report, click here.
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