Reports: AMA supports legislation against ‘pay-for-delay’ deals
NEW YORK — The American Medical Association has come out in favor of legislation to stop deals between branded and generic drug makers that critics blame for delaying entry of generics into the market, according to published reports.
Forbes reported that the AMA would support federal legislation to ban so-called "pay-for-delay" settlements. The AMA joins the Federal Trade Commission, which has strongly criticized the settlements
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 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.
According to the Generic Pharmaceutical Association, a trade group, the settlements usually result in the generic drug becoming available ahead of patent expiration, and delaying entry beyond the expiration would be illegal.
Towers Watson names Loblaw Companies preferred pharmacy for Towers Watson Canadian Rx Coalition
TORONTO — Towers Watson on Tuesday announced that it has selected Loblaw Companies as the preferred pharmacy services provider for its Towers Watson Canadian Rx Coalition, a collaborative network of private sector drug plan sponsors.
The arrangement with Loblaw is expected to improve employers’ ability to offer their employees access to a robust range of drug store health resources and support overall health and wellness needs while enabling long-term sustainability of their benefits programs in the face of rising costs.
With approximately 500 pharmacies today in its network of banners, Loblaw is one of the largest full-service retail drug retailers operating in Canada, Towers Watson reported. Loblaw offers a variety of patient education programs and in-store dietitians to address the health and wellness needs of customers, and its stores are home to more than 100 medical clinics, 100 optical shops and 60 Goodlife Fitness facilities.
NCPA survey: Most independents provide compounding services
ALEXANDRIA, Va. — As many as 85.5% of independent community pharmacies offer patients traditional compounding services, and while it accounts for a small portion of their business, the health-enhancing effect for patients can be dramatic, according to a new survey released Tuesday by the National Community Pharmacists Association.
Of those pharmacists who compound medications, nearly two-thirds reported the medications made up less than 5% of their pharmacy practice. Nearly 3-out-of-4 compounding pharmacists only provide nonsterile medications. Despite the fact that traditional compounding only represents a fraction of their business, 70% of pharmacists report participating in ongoing training/educational courses related to compounding techniques. This training is in addition to any continuing education that may be required to sustain one’s license as a pharmacist, NCPA reported.
“This survey offers fresh evidence that traditional compounding services are a saving grace for patients when mass-produced drugs aren’t available or are not appropriate for the patient,” stated Douglas Hoey NCPA CEO. “Pharmacists will continue to work constructively with Congress and other policymakers to not only help prevent another crisis like the [recent] meningitis outbreak, but to also preserve patients’ access to customized and safe compounded medications," he said.
“Pharmacists are appalled by the reported actions of the rogue drug manufacturer at the center of the tragic, nationwide meningitis outbreak,” Hoey said. “It purported to be a pharmacy, but its actions told another story. It’s disappointing that regulators did not act sooner to prevent patient suffering.”
Pharmacists and other experts consider the cornerstone of traditional pharmacy compounding to be the preparation of customized medications on a patient-by-patient basis in response to the request of a doctor or other prescriber. The practice is most commonly employed when manufactured drugs are not appropriate for a particular patient, such as children or those with allergies, or when mass-produced medicines are not available.