Pay-to-Delay Supreme Bound?
Last month, the 3rd Circuit Court of Appeals surprised everyone when they ruled in In re K-Dur Antitrust Litigation that the standard “pay-for-delay” deals violate antitrust law. These deals are exactly how they sound: Brand-name drug manufacturers delay the release of generic competition by paying off generic-makers.
These agreements started after the passage of the Hatch-Waxman Act in 1984, which established that generic-makers must prove their new drug does not violate any current patents at the FDA and occasionally means challenging the validity of a brand’s patent. The brand-manufacturer, however, makes it worthwhile for the generic-maker to hold off on this challenge until after the brand loses its exclusivity. The FTC has argued for years that these deals should be illegal (they cost consumers an extra $3.5 billion a year), but court after court—the 2nd Circuit, the 11th Circuit and the D.C. Circuit—all ruled in favor of the deals as long as they don’t postpone generics past the brand’s patent expiration.
The 3rd Circuit Court’s decision means the Supreme Court is now likely to get involved, so the true impact to the industry is unclear at this time. Ralph G. Neas, President and CEO of The Generic Pharmaceutical Association, called the ruling “inconsistent” and added: “Pro-consumer patent settlements have never prevented competition beyond a patent’s expiration. Indeed, they have resulted in making lower-cost generics available months and even years before patents have expired, saving consumers billions of dollars.”
Time With Patients and Tech
It’s no secret that these days doctors are short on time. According to Everyday Health’s MedPage Today survey of physicians, Today’s Physician: Managing Change, doctors reported a 43% increase in the number of weekly patients. This has left docs with less time to spend with each patient as well as less time to attend conferences, read journals and meet with pharmaceutical reps. The one thing they do make time for, however, is the Internet. More than two-thirds spend three or more hours on a computer each day and 40% spend over three hours on a mobile device—with catching up on medical news the number one reason for using either device. Eight in 10 doctors also believe that technology is helping to improve communications with patients in all age demographics.
“Today’s physicians are heavy users of technology in both their professional and personal lives,” says Dr. Kevin Pho, MD, founder of KevinMD.com and a leading physician voice within the social media space. “There is, however, a gap between how they would like to use technology at work and what they can do with it today. The interest is there, now we need solutions that can help the patient and physician in a simple and seamless way.”
iPad Gives Reps More Face Time
A recent survey may have answered the age-old question that sales reps have pondered for years, “Once I get in the door, how can I get the physician hooked?” It’s simple: Use an iPad. MD Mindset, a life sciences and healthcare marketing intelligence firm founded by doctors, recently conducted a survey of 1,500 doctors in 15 different specialties that found the iPad to be doctors’ visual aid of choice in sales presentations. One finding was particularly striking: The use of an iPad virtually eliminated the blink-and-you-miss-it sales call. In fact, the two-minute (or less) sales call dropped from 42.7% to 4.2% when an iPad was used.
“With less time to see sales professionals,” says Peter Shaw, M.D., the president of MD Mindset, “doctors need better visual aids to assimilate important information that may assist them in changing their clinical or prescribing behavior.”
Therapeutic Talk: Cardiology
A Closer Look At Statin Adherence
Why do people on statins stop taking their medications? A recent study of more than 10,100 statin users conducted by The National Lipid Association (NLA), Kowa Pharmaceuticals America, and Eli Lilly and Company— Understanding Statin use in America and Gaps in Education (USAGE), found that most people stop due to side effects (62%) or cost (17%), followed by lack of treatment efficacy (see chart below). Another “scary” finding— according to Lisa Garman, Associate Director of Marketing for Kowa—is the lack of knowledge about the potential for drug-drug interactions (DDI). Only 38% of all respondents were concerned about DDI, while even fewer (26%) proactively spoke to their doctors about it. Garman believes this lack of communication could be a reason behind discontinued statin use.
“Based on the other answers that respondents gave,” began Garman, “the NLA suspects that the side effects weren’t from either one of the medications directly, but more likely from the DDI caused by taking multiple medications that take the same pathway in the liver. If we can get physicians and patients to have improved dialogue about what they are putting into their body then you can increase the odds for success.” For downloadable patient- and medical provider-directed Discussion Guides and a Medication Tracker for patients, go to the USAGE survey website at statinusage.com.
HIV Drug Approved
The FDA has HIV news of its own. Gilead Sciences’ Truvada (emtricitabine/ tenofovir disoproxil fumarate) is the first drug approved to reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection and who may engage in sexual activity with HIV-infected partners. Truvada must be taken daily and used in combination with safer sex practices. Meanwhile, OraSure Technologies’ OraQuick In-Home HIV Test is the first OTC home-use rapid HIV test kit approved to detect the presence of antibodies to HIV-1 and HIV-2.
Weight-Loss Pills Okayed
After 13 years passed without the FDA approving any new weight loss pills, the agency approved two in the span of two weeks. Vivus Inc.’s Qsymia (phentermine and topiramate extended-release) and Arena Pharmaceutical and Eisai’s Belviq (lorcaserin) were both approved as an addition to a reduced-calorie diet and exercise for chronic weight management for adults with a body mass index (BMI)
of 30 or greater or adults with a BMI of 27 or greater who have at least one weight-related condition such as high blood pressure, type 2 diabetes, or high cholesterol.
Breast Cancer Combo
Novartis’ Afinitor (everolimus) was approved for use in combination with Aromasin (exemestane) to treat certain postmenopausal women with advanced hormone-receptor positive, HER2-negative breast cancer. This combo therapy is intended for use in women with recurrence or progression of their cancer after treatment with Femara (letrozole) or Arimidex (anastrozole).
REMS for Opioids
The FDA released a new risk evaluation and mitigation strategy (REMS) for extended-release and long-acting opioids. The new opioid REMS will affect more than 20 companies that manufacture these opioid analgesics.