Supreme Court hears patent-settlement case
NEW YORK — The Supreme Court heard arguments Monday in a case that could determine the future of generic drugs in America.
The case, Federal Trade Commission v. Actavis, marks the latest attempt by federal authorities to put an end to what they say are deals between branded and generic drug companies that delay release of generic drugs to consumers.
The case centers on a common practice in which a generic drug company that wishes to market a version of a branded drug before its patent expires files an approval application with the Food and Drug Administration containing a Paragraph IV certification, a legal assertion that the patent is invalid, unenforceable or won’t be infringed. In response, the branded drug company will generally file a patent-infringement lawsuit to stop the FDA from approving the drug. The companies will often reach a settlement that ultimately allows the generic drug company to launch well before patent expiration, and under current laws, a generic version must be launched by the time the patent expires anyway.
For the FTC, as well as many members of Congress and consumer groups, the issue is when the generic drug company agrees to hold off launching the drug in exchange for some type of consideration from the branded drug company, such as monetary payment or an agreement by the latter not to launch a cheaper version of the drug through a third-party company, also known as an authorized generic. Opponents of such deals call them "pay-for-delay" settlements and contend that they keep drugs out of the hands of consumers for longer than if no settlement had taken place.
"If there’s money on the table, the generic firm will accept a later entry date," David Balto, former FTC policy director under the Clinton administration, who filed an amicus brief with the court in support of the FTC’s position, told Drug Store News. "If there’s no money on the table, the generic firm will bargain for the earliest possible entry date."
Balto expressed optimism for the FTC side, saying that the court appeared highly skeptical of the generic drug industry’s position. "Ultimately, this will be very good for consumers because the FTC’s position will get generic drugs into the hands of consumers faster," Balto said.
Meanwhile, the Generic Pharmaceutical Association (GPhA) contends that the settlements are ultimately pro-consumer because they get generic drugs to the market months or years ahead of patent expiry. The group points to a 2010 study by the Royal Bank of Canada of 370 patent-litigation suits, which found that when the suits went to trial, the generic drug industry prevailed 48% of the time, compared with 76% of the time when litigation was settled.
"The FTC’s case is built on a house of cards," GPhA president and CEO Ralph Neas said in a conference call with reporters Monday, saying the agency’s position relied on "assumptions and methodologies that are false" and based on a study more than 10 years old.
"We believe the FTC’s position, if upheld by the court, would harm consumers," Actavis president and CEO and former GPhA chairman Paul Bisaro said in the call.
In the Senate, a bill is under consideration that would also seek to restrict patent settlements between branded and generic drug companies. In a recent white paper, former Clinton administration solicitor general Paul Bender called the bill, S. 214, "hopelessly flawed," saying it would interfere with litigant rights to settle, create unfair burdens of proof, conflict with the statutory presumption of patent validity, frustrate provisions in the Hatch-Waxman Act of 1984 that favor litigation and preclude settlements.
"Rather than adopting that unusual and dangerous solution, the government should utilize the tools it has in hand under the Medicare Modernization Act of 2003 that require the FTC to review and prove the illegality of settlements on a case-by-case basis," Bender wrote.
CVS/pharmacy’s new iPad App features 3-D virtual store, digital pharmacy experience
WOONSOCKET, R.I. — CVS/pharmacy has launched a first-of-its-kind interactive app, delivering a virtual 3-D digital drug store experience for customers using Apple iPads.
With the new CVS iPad app, customers can explore a virtual 3-D CVS/pharmacy and access services from the pharmacy, ExtraCare, photo center and MinuteClinic, as well as browse departments to shop.
Designed to present a fun and interactive pathway to shop CVS/pharmacy and fill prescriptions, the CVS iPad app was developed using technologies that bring to life a customized drug store that customers can access with their fingertips, on-the-go or from the comfort and privacy of their own home.
"As a pharmacy innovation company, CVS/pharmacy is committed to deploying new and emerging digital technologies that empower our customers on their path to better health," stated Brian Tilzer, SVP and chief digital officer for CVS/pharmacy. "The new CVS iPad app provides the millions of customers who visit CVS.com on a tablet device each month with a virtual feeling of visiting their neighborhood CVS/pharmacy from their home or on the go. Our app makes it unbelievably easy for customers to shop, fill prescriptions, manage their ExtraCare accounts and more through a highly personalized experience and 3-D realism."
Available for free on iTunes, the CVS iPad app incorporates an interactive, user-friendly, virtual CVS/pharmacy interface that relies on gesture-based movements that are native to touchscreen tablet environments. Tapping on popular areas of the store from the home screen will launch mini apps for different parts of the store, including:
Pharmacy services with enhanced prescription management: With the swipe of a finger, customers can scroll through all their prescriptions in a matter of seconds and take actions, including scheduling refills and viewing prescriptions available for pickup. Caregivers can manage prescriptions for themselves and their families using native tablet functionality, such as drag-and-drop, and easily sort by patient name and refill status. Patients also can view prescription details instantly with zoom-in detail screens and scan-in refills using the iPad camera (supported on iPad 3 and above).
ExtraCare with coupon center: Shoppers can sign in to manage their ExtraCare savings and rewards by clicking the ExtraCare Coupon Center. The ExtraCare mini app allows visitors to check their balances or sign up for additional ExtraCare programs, such as Beauty Club, ExtraCare Advantage for Diabetes and ExtraCare Pharmacy & Health Rewards. Similar to the in-store experience, customers are encouraged to make the ExtraCare Coupon Center their first stop to receive new coupons and personalized offers. On the CVS iPad app, they can view what offers are available with easy rotating display and animations, and then choose to send them directly to their ExtraCare card or print them.
Weekly ad: Customers looking for deals or customers who prefer to plan ahead can view the weekly circular for their preferred location by using the GPS locator or entering their ZIP code. In addition, customers can search the ad by category or brand, or search for a specific product and build shareable shopping lists.
Catalogue style shopping: Users can shop and search the full CVS.com product catalog, sorted by category. Shoppers can also access weekly deals to take advantage of new offers every day on popular household essentials, beauty products, health needs and gifts.
Photo center: App users can upload photos from their tablet camera roll to be printed for pickup that very same day at a local CVS/pharmacy. Customers can also see various other photo products available in-store.
MinuteClinic: Users can quickly locate the nearest MinuteClinic or access a variety of informational resources on the types of services and minor illness exams offered, as well as check the various kinds of insurance accepted.
CVS/pharmacy stated that in the coming months it will introduce support for additional tablet platforms and will continue to enhance the CVS iPad app.
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FDA approves Novartis antibacterial treatment for cystic fibrosis
EAST HANOVER, N.J. — The Food and Drug Administration has approved a treatment for managing a type of bacterial infection in patients with cystic fibrosis.
Swiss drug maker Novartis announced the approval of Tobi Podhaler (tobramycin inhalation powder) for managing cystic fibrosis patients with Pseudomonas aeruginosa, or Pa bacteria, in the lungs.
Novartis called the product the only FDA-approved dry-powder inhaled antibacterial for Pa in the United States, and the company said it shortened the time needed to administer the drug by 70% in clinical trials. In other treatments, tobramycin is administered using a nebulizer.
"This is good news for the CF community," Cystic Fibrosis Foundation president Robert Beall said. "Managing daily CF treatments is a challenge for people with CF."