‘Pay for delay’ deals will face review by SCOTUS
The nation’s highest court has agreed to hear three cases stemming from the longstanding but controversial practice by which branded and generic drug makers agree to delay introduction of a me-too medicine as its brand-name counterpart nears the end of its patent protection. A ruling by the Supreme Court could alter the delicate balance sometimes struck between the two industries as they scramble to either delay or hasten the onset of generic competition for big-selling, patented drugs.
The high court revealed in December it would take up the cases, which stem from court challenges filed by the Federal Trade Commission and some pharmacy chains over the practice of so-called reverse payments. Critics deride the settlements, by which a generic manufacturer will agree to delay introduction of a cheaper alternative to a branded drug facing the end of its patent life, in return for monetary or other compensation.
Such “pay for delay” settlements, challengers assert, illegally reduce competition and cost U.S. consumers and health plan payers $3.5 billion a year in higher-than-necessary drug costs.
Three generic companies — Watson Pharmaceuticals, Par Pharmaceuticals and Solvay Pharmaceuticals — are bundled into the case the high court will take up, possibly in March.
Typically, when a generic drug company wants to be the first to market a generic version of a drug, it will file for Food and Drug Administration approval for it before the branded drug has lost patent protection. This usually prompts a patent-infringement lawsuit from the branded drug company, and while the suits often go to trial, in many cases, they will result in a settlement that allows the generic drug maker to launch at a later date.
While the “pay” part of the deal may be monetary, it frequently consists of a promise on the part of the branded drug maker not to market an authorized generic — essentially the branded drug marketed at a discount under its generic name, usually by a third-party company — during the 180-day market exclusivity period to which generic companies are entitled if they are the first to win approval for a generic, when they have the sole right to compete against the branded version.
Among critics of the practice: FTC chairman Jon Leibowitz, who said the agreements “leave American consumers footing the bill.” Both branded and generic drug groups, however, counter that reverse payments get drugs into the hands of consumers faster than they would if the patent-infringement suits went to court.
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Smartphones driving mobile health revolution
“A drug store in the palm of your hand.” That’s what Walgreens calls the fast-growing suite of health and pharmacy services now available from many retail pharmacies to Americans with smartphones.
Technology vendors, pharmacies and other health providers are keeping pace with a slew of interactive health offerings. For proof, one need look no further than the nation’s biggest drug store retailers.
CVS Caremark, for instance, saw a huge uptick in activity among consumers linking to its pharmacy services via smartphones. The number of “customers accessing CVS.com via mobile devices and tablets has more than doubled since the beginning of the year,” said Rob Price, SVP and chief marketing officer for CVS/pharmacy.
Responding to its customers’ demand for mobile access and convenience, CVS has added new features to its mobile Web platform and a suite of apps that already included such features as prescription bar code scanning for smartphone users to make refills easier. Among the new applications: an immunization scheduling tool that allows customers to set up a flu shot appointment at a nearby CVS pharmacy from anywhere, see when prescriptions are ready for pickup, access a Health Information Center and manage their ExtraCare savings and rewards. The enhanced CVS mobile apps also include a new Pill Identifier tool, giving patients a way to check for drug interactions and identify pills by shape, color and imprint.
The pioneer in scan-driven mobile-based refills is Walgreens, which launched its Refill by Scan mobile app in November 2010 and saw a nearly fivefold increase in mobile applications in 2011. Refill by Scan now accounts for more than 40% of all online refills, according to the company, and generates more transactions than any other mobile app feature for Walgreens.
“As we put new smartphone enhancements in the hands of Walgreens customers nationwide, the response has been phenomenal,” Walgreens president and CEO Greg Wasson noted. Customers, he said, quickly embraced new mobile apps like scan-driven refills, with nearly 3 million downloads in its inaugural year.
“We’ve extended the convenience of Walgreens pharmacy through a number of intuitive, easy-to-use tools that can be very effective in helping patients better manage and improve their overall health,” said Sona Chawla, Walgreens president of e-commerce.
Also scoring with tech-savvy consumers in 2012 was Rite Aid, which last year gave users of Android and iPhone devices easier access to its suite of Web-based and mobile services with a more powerful and simpler-to-use mobile app for text messaging, prescription alerts and refill reminders, among other services. “We’ve seen traffic to our mobile-optimized website grow steadily as proof positive that our customers’ communication preferences are evolving,” said John Learish, SVP marketing.
The ability of pharmacy retailers to rapidly adapt is a positive development for a health system scrambling to deliver care.
“With the rapid growth of mobile health, usability of mobile applications is critical, as these applications present the opportunity to improve clinical and financial performance and to address the growing problem of chronic care,” HIMSS reported recently.
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Reports: Otsuka can block Apotex’s generic version of Abilify
NEW YORK — Drug maker Otsuka Pharmaceuticals can keep generic versions of its schizophrenia drug off the market, according to published reports.
Bloomberg reported that the Supreme Court upheld a ruling that allowed Otsuka to block Canadian generic drug maker Apotex from marketing a version of the antipsychotic Abilify (aripiprazole), which Otsuka co-markets with Bristol-Myers Squibb.
Apotex attempted to argue that because any person with the right skills could create a version of Abilify’s active ingredient sufficiently identical to the original, and that the ingredient belonged to a class of drugs that had existed since the early 1980s. But the high court upheld a ruling in a lower court rejecting those claims.
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