FDA commissioner calls for power to regulate compounding pharmacies
SILVER SPRING, Md. — The commissioner of the Food and Drug Administration is renewing calls for legislation to give the agency more authority to regulate pharmacy compounding.
In a blog post Friday, Margaret Hamburg wrote that while the FDA has inspected more than 30 compounding pharmacies and worked to inspect state-licensed pharmacies that produce sterile drug products, the agency’s authority remained limited and was "not the right fit for FDA to provide appropriate and efficient oversight of this growing industry."
In the past week, Hamburg wrote, there were two recalls of sterile compounded and repackaged drug products due to contamination. In one case, five patients were diagnosed with serious eye infections after receiving doses of Genentech’s Avastin (ddd) from a compounding pharmacy in Augusta, Ga. In another, fungus was found in bags of magnesium sulfate intravenous solution.
"There is a legitimate role for traditional pharmacy compounding," Hamburg wrote. "Every day, thousands of pharmacists practice traditional pharmacy compounding — mixing a drug in response to a valid prescription for an individual patient’s need." These include liquids for patients who can’t swallow pills, or medications made for patients allergic to certain ingredients.
But sterile compounding, Hamburg wrote, has evolved and "outgrown the law." Sterile compounding is a much more complex process and requires careful attention to sanitation. It generally involves medications designed for intravenous delivery.
Sterile compounding has received significant attention in recent months following a nationwide outbreak of fungal meningitis among patients who received injected steroids from the New England Compounding Center in Framingham, Mass. An investigation of the NECC found widespread contamination, disregard for safety standards, and former employees of the pharmacy have said that it had essentially become a manufacturer. According to the Centers for Disease Control and Prevention, 722 have become sick with the meningitis, and 50 have died.
Walgreens, Alliance Boots and AmerisourceBergen help redefine economies of scale
Walgreens and Alliance Boots entered into a 10-year contract with wholesaler AmerisourceBergen on sourcing pharmaceuticals last week. But that’s not all. Besides the long-term contract, Walgreens and Alliance Boots will have the option on a potential 23% equity stake in ABC in three years.
The deal takes pharmaceutical buying leverage to the stratosphere and changes the face of more than one health service industry. As Adam Fein, president of Pembroke Consulting, noted in a live TV interview on Fox Business’ "Money With Melissa Francis": "Three of the largest companies in the pharmaceutical industry have come together and built the single largest buyer of prescription drugs in the world," he said.
Specifically, it creates a generic acquisition juggernaut. And that’s important, Fein suggested, because by the time this deal becomes fully consummated in 2016, 90% of all medicines dispensed at the pharmacy will be generic medicines. That’s not good news only for Walgreens and Alliance Boots; that’s good news for anyone who chooses to buy their generics from ABC. The way the deal is structured, Fein noted in his blog on the deal, ABC will be able to leverage the collective buying power of Walgreens, Alliance Boots and every pharmacy customer who buys their generic drugs from ABC.
But pharmaceutical acquisition isn’t the only potential synergy here, especially when you factor in the equity stake. There’s also the potential collective bargaining power of close to 12,000 retail pharmacy outlets, between Walgreens and ABC’s Good Neighbor Pharmacy Provider Network, that can be leveraged against pharmacy benefit manager contracts. And with the addition of the independent GNP base, that combination makes for a pretty extensive health cost containment tool (think medication therapy management, disease state management, immunizations, nutrition counseling, smoking cessation programs) that can be tapped into by the national employers and health insurers that Walgreens has been regularly engaging.
Both Fein and management consulting firm Blue Fin Group’s Bill Roth see the next step for Walgreens and ABC is to go into self-manufacturing on "generics, private label and anything that resembles a commodity item including DME." Roth goes on to suggest that other retailers will be forced into vertical integration. "Net net as other retailers and distributors think it through, this may force other deeper partnerships to develop. … Think of it like a game of musical chairs for really large players."
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Novo Nordisk drug produces significant weight loss in study
BAGSVÆRD, Denmark — A drug made by Novo Nordisk for Type 2 diabetes produced a 6% loss of weight in a trial of the drug in obese patients, the company said.
The Danish drug maker announced results of a 56-week phase-3 trial to investigate the potential of Victoza (liraglutide) to produce and maintain weight loss in overweight and obese patients with Type 2 diabetes.
The trial enrolled 846 overweight and obese people who received 3 mg of Victoza, 1.8 mg of Victoza or placebo. Patients were followed for 12 weeks after the study ended at 56 weeks. Patients treated with the 3-mg and 1.8-mg doses of Victoza achieved weight loss of 6% and 5%, respectively, compared to 2% in the placebo group, the study found.
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