Industry divided over patent settlements
Patent settlements between generic and branded drug companies seem like one of the most controversial and long-standing issues in the pharmaceutical world, with strong opinions on both sides.
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 the generic before the branded drug has lost patent protection. This usually prompts a 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. Critics call these settlements “pay-for-delay” deals, the idea being that they result in generic drugs getting into patients’ medicine cabinets later than they would if there had been no deal.
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.
Last month, the American Medical Association became the latest player to make its voice heard when it came out in support of getting rid of the settlements. The AMA joins the Federal Trade Commission — which, under chairman Jon Leibowitz, has been aggressive in its criticism of many patent settlements — as well as legislators like Sens. Herb Kohl, D-Wis., and Chuck Grassley, R-Iowa.
In October 2012, the U.S. solicitor general, on behalf of the FTC, petitioned the Supreme Court to review an appeals court ruling concerning the agency’s case against an agreement over the testosterone-replacement drug AndroGel. Originally filed in February 2009, the case alleges that Solvay Pharmaceuticals paid generic drug makers Watson Pharmaceuticals, Paddock Labs and Par Pharmaceutical millions of dollars per year to delay introducing generic versions of the drug and refrain from marketing them until 2015.
But the Generic Pharmaceutical Association counters that despite the settlements, generic drugs still become available months or even years ahead of the expiration of branded drug makers’ patents, and delaying launch of a generic beyond patent expiry would be illegal anyway. The patent covering AndroGel expires in August 2020, according to FDA records. And according to a report by RBC Capital Markets, generic drug companies win 48% of patent litigation settlements that go to trial, but their success rate increases to 76% when settlements are included.
ReportersNotebook — Chain Pharmacy, 12/10/12
SUPPLIER NEWS — MediSafe Project has launched what it called the first cloud-synced mobile app to help prevent emergencies caused by over- or under-dosing medications.
NCR Corp. is partnering with health kiosk maker SoloHealth to provide on-site repairs to its interactive consumer healthcare kiosks at retailers as SoloHealth rolls them out around the country. The stations provide screenings for vision, blood pressure, weight, symptoms checking, body mass index and overall health.
TCE Group announced the introduction of its Pharma Kiosk, or PK+. The kiosk allows patients to order prescription drugs through an Internet connection and is designed to be located at any site, including such remote locations as office towers and shopping malls.
RETAIL NEWS — Kerr Drug has broadened its services with a new mobile pharmacy application. Powered by mScripts, the solution enables Kerr Drug customers to refill prescriptions and receive pickup and dosage reminders through the convenience of their mobile phones. Smartphone users can access the store locator, weekly specials and do a quick refill by scanning the QR code on prescription bottles. A text-messaging option for nonsmartphone users enables patients to receive many of the same benefits.
Pharmaca Integrative Pharmacy has launched a mobile app for patients to manage their prescriptions. The app, which operates on a secure network created by San Francisco-based mScripts, includes dosage reminders, health information and features for getting prescription refills and pickup reminders. The company also launched a new mobile website at M.pharmaca.com.
EHRs boost adherence, monitoring in diabetics
Use of electronic health records improves medical outcomes among patients with diabetes, according to a recent study conducted by Kaiser Permanente.
The study, published in the Annals of Internal Medicine, found that use of EHRs was associated with improved increases in medication, monitoring and risk-factor control among patients with the disease. Researchers also found greater improvements among patients with poorer control of diabetes and cholesterol. The study included 169,711 patients with diabetes at 17 medical centers in Kaiser Permanente’s Northern California integrated care delivery system between 2004 and 2009.
“What we saw in this study is that the EHR really helped our alignment with quality measures and clinical guidelines for treatment,” Kaiser Permanente Northern California Cardiovascular Risk Reduction Program director Marc Jaffe said. “Increases in information availability, decision support and order-entry functionality help clinicians to identify the most appropriate patients for drug-treatment intensification and retesting, which leads to better care of patients with diabetes.”
The study found statistically significant improvements in medication increases, also known as drug-treatment intensification, in patients with HbA1C levels of 7% or greater. Ultimately, the researchers found that use of an electronic health record resulted in better HbA1C levels and levels of low-density lipoprotein or “bad” cholesterol. The study involved more than 1.37 million HbA1C tests and more than 1.27 million LDL cholesterol tests.
A previous study, published in 2010 in the journal Health Affairs, involved 35,423 Kaiser Permanente diabetes and hypertension patients in southern California and found that secure patient-physician messaging in any two-month period resulted in improvements in healthcare effectiveness measures, including improvements of between 2% and 6.5% in blood sugar, cholesterol and blood pressure screening and control.
“Our next step is to see how EHR use improves downstream clinical events in patients with diabetes,” lead author of the most recent study, Mary Reed, said. “Since we have found that glycemic control and lipid levels were better, now we need to better understand if EHR use impacts measurable events like emergency room visits. This would be an important step in evaluation of the impact and potential value of electronic health records.”
EHRs have seen significant growth in recent years, spurred by financial incentives for healthcare providers who adopt them as part of the American Recovery and Reinvestment Act of 2009. Last year, 55% of physicians had adopted an electronic health record system, according to a study released in July by the Centers for Disease Control and Prevention. Electronic prescribing has likewise seen tremendous growth. According to Surescripts, 58% of office-based physicians were using e-prescribing by the end of last year, as well as 91% of retail pharmacies. In July 2012, Minnesota was ranked first in the country for use of e-prescribing in Surescripts’ seventh annual Safe-Rx Awards, with 61% of prescriptions routed electronically in the state.