- GPhA: FDA’s proposed rule on prescription drug labeling adds $4 billion to healthcare costs
- Senate passes Drug Quality and Security Act
- Americans more likely than others to prefer generics, study finds
- NACDS, NCPA, GPhA express support for Drug Quality and Security Act
- Roxane Labs' generic prostate drug gets tentative approval from FDA
Generic drug usage already has been on the rise year after year, with no sign of slowing down. As Jody Fisher, VP marketing for healthcare analytics at market research firm SDI, has told Drug Store News, generics accounted for more than 70% of products dispensed at retail pharmacies and are set to increase further this year.
But a recent recommendation by the Department of Health and Human Services could boost generics even more. In a document released earlier this month, HHS secretary Kathleen Sebelius urged governors of all 50 states to increase use of generics in state Medicaid programs, winning praise from such groups as the Pharmaceutical Care Management Association, a trade group representing pharmacy benefit managers. According to the Generic Pharmaceutical Association, Texas was able to save about $223 million by changing prescription pads to make it easier for doctors to prescribe generics, while federal and state governments together could save more than $2.9 billion per year with a 5% increase in generic utilization.
But generic drug makers could face some trouble as well, particularly with a bill proposed in early February by Sen. Patrick Leahy, D-Vt., which would make the biggest changes to patent laws in more than 60 years. While the GPhA and the Pharmaceutical Research and Manufacturers of America — the lobby that represents branded drug companies — both praised the bill on the whole, the GPhA expressed concerns about changes that it said could weaken the inequitable conduct provision, a provision that has enabled generic drug companies to challenge patents covering branded drugs. “We don’t think that patent reform should weaken the inequitable conduct provision,” GPhA interim executive director Bob Billings told DSN. “If it does, you’ll see slower times for generics to come to market.”
Currently, a patent can be ruled invalid in court if the court determines that the patent holder intentionally withheld information or deceived the Patent and Trademark Office. Generic drug companies wishing to launch before the branded version’s patent expires will include in their regulatory filing with the Food and Drug Administration a Paragraph IV certification, a legal assertion that the patent is invalid, unenforceable or won’t be infringed. If the judge can find inequitable conduct, the generic company can launch its version of the drug. Generally, the branded drug company will file a lawsuit, but in most cases, the two reach a settlement that still allows generic launch ahead of patent expiration.