PHARMACY

Industry advocates tout
 increase in generics use

BY Alaric DeArment

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.

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PHARMACY

Tech, interconnectivity 
focus of NCPDP summit

BY Amanda Baltazar

Technology is not only bringing more benefits to patients in the pharmacy, but it’s also offering them a host of products so they can be more involved in their health care. This was a theme at the National Council for Prescription Drug Programs’ educational summit, “Leveraging New Technologies: Impact on the Patient and the Healthcare Industry,” on Feb. 8 in Las Vegas.


Devices from blood-glucose monitors to personal EKG machines have been around for a while, but now these products talk to each other. They also tie in with exercise machines and physical activity monitors to send information to a patient’s smart phone. This allows patients to monitor their own health and easily send snapshots of health data to a physician, caregiver or pharmacist.


Combining physical activity and health monitoring is a prominent, practical implementation of device connectivity. There is now a range of fitness products that can be used for health care — straps to measure breathing or heart rate, for example — that will send information to a phone. That information can then be amalgamated with that from other health devices to provide a broader picture of a consumer’s health.


“The interconnectivity of devices is a key thing right now,” said Scott Robertson, co-chair of the NCPDP educational programs committee and principal technology consultant in health IT strategy and policy for Kaiser Permanente Information Technology. “That information can be forwarded from a smart phone or computer (a hub) to a caregiver, doctor or pharmacist, so if [patients are] starting to go in the wrong direction, they can get feedback quickly.”


However, Robertson sounded a note of caution. It’s worth thinking about the security of all of this data that consumers are collecting and sending, Robertson advised. It may not seem of any importance if a person’s blood-pressure readings fall into the wrong hands; but at some point, it could be very disadvantageous.

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ReportersNotebook — Chain Pharmacy, 2/28/11

BY DSN STAFF

SUPPLIER NEWS — Drug maker Valeant Pharmaceuticals International has acquired U.S. and Canadian rights to certain formulations of a GlaxoSmithKline drug used to treat cold sores. Valeant acquired the rights to nonophthalmic topical formulations of Zovirax (acyclovir) from GSK for $300 million through its Canadian subsidiary, Biovail Labs.



The Food and Drug Administration declined to approve a drug made by Eisai for treating gastroesophageal reflux disease, Eisai said. The drug maker announced its receipt of a complete response letter from the agency for its application for rabeprazole sodium extended-release capsules, a proton-pump inhibitor for GERD. The FDA delivers a complete response letter when it has finished reviewing a regulatory approval application, but issues remain that preclude final approval of the drug.



The Food and Drug Administration has approved a generic weight-loss drug made by Elite Pharmaceuticals. Elite announced the approval of phentermine hydrochloride in the 37.5-mg strength, a generic version of Teva’s Adipex-P. Branded and generic versions of the drug had sales of around $40 million in 2010, according to Elite.



The Food and Drug Administration approved Sun Pharmaceutical Industries’ generic version of Johnson & Johnson’s Alzheimer’s drug, Razadyne (galantamine hydrobromide) tablets. Razadyne has annual sales of about $50 million, according to Sun.

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