Content about Regulatory and Washington

November 8, 2013

When the maker of a branded drug updates the safety information on its product labeling, makers of generic versions of that drug must wait until the Food and Drug Administration approves the new labeling before they can update theirs, but that could soon change under a rule proposed by the FDA.

SILVER SPRING, Md. — When the maker of a branded drug updates the safety information on its product labeling, makers of generic versions of that drug must wait until the Food and Drug Administration approves the new labeling before they can update theirs, but that could soon change under a rule proposed by the FDA.

November 8, 2013

Boehringer Ingelheim SVP managed markets Jeff Huth has been elected by the National Pharmaceutical Council as chairman of the board for 2013-2014, the organization said Friday.

WASHINGTON — Boehringer Ingelheim SVP managed markets Jeff Huth has been elected by the National Pharmaceutical Council as chairman of the board for 2013-2014, the organization said Friday.

Huth has served as a member of the NPC's board since 2009 and has previously had the positions of vice chairman and treasurer. The NPC, founded in 1953, describes itself as a health policy research organization focused on the advancement of science and medical innovation.

November 8, 2013

The retail industry added 37,600 jobs in October, and 295,000 year-over-year, according to a new report by a retail industry trade group.

WASHINGTON — The retail industry added 37,600 jobs in October, and 295,000 year-over-year, according to a new report by a retail industry trade group.

Analysing numbers from the Bureau of Labor Statistics, the National Retail Federation said the increase represented 2.4% boost over 2012, and every sector of retail added jobs except clothing retailers, which lost 12,500 jobs. Overall, according to the BLS, the economy added 204,000 jobs in October, and the unemployment rate was 7.3%.

November 7, 2013

U.S. regulators made a preliminary move Thursday to remove trans fats from food products.

SILVER SPRING, Md. — U.S. regulators made a preliminary move Thursday to remove trans fats from food products.

November 7, 2013

A former executive from Cisco has been appointed as CEO of the International Diabetes Federation.

BRUSSELS — A former executive from Cisco has been appointed as CEO of the International Diabetes Federation.

The IDF announced Thursday the appointment of Petra Wilson, who formerly served as Cisco's senior director of the European health and care business solutions team, working with the World Health Organization, the European Commission, governments and others.

November 7, 2013

New Senate legislation introduced Tuesday that would restore consumers’ ability to use pre-tax dollars from flexible spending accounts and health savings accounts to purchase over-the-counter medicines without first seeing a doctor has been jointly endorsed by the National Association of Chain Drug Stores and the National Community Pharmacists Association.

ALEXANDRIA, Va. — New Senate legislation introduced Tuesday that would restore consumers’ ability to use pre-tax dollars from flexible spending accounts and health savings accounts to purchase over-the-counter medicines without first seeing a doctor has been jointly endorsed by the National Association of Chain Drug Stores and the National Community Pharmacists Association. 

November 7, 2013

Sen. David Vitter, R-La., is holding up a vote on a measure that would strengthen regulations on compounding pharmacies in order to alter a provision of the Patient Protection and Affordable Care Act, according to published reports.

NEW YORK — Sen. David Vitter, R-La., is holding up a vote on a measure that would strengthen regulations on compounding pharmacies in order to alter a provision of the Patient Protection and Affordable Care Act, according to published reports.

November 6, 2013

U.S. Sens. Pat Roberts, R-Kan., and Mary Landrieu, D-La., on Tuesday introduced legislation that repeals a portion of Obamacare that prohibits people from using their medical savings account funds to buy over-the-counter medications.

WASHINGTON — U.S. Sens. Pat Roberts, R-Kan., and Mary Landrieu, D-La., on Tuesday introduced legislation that repeals a portion of Obamacare that prohibits people from using their medical savings account funds to buy over-the-counter medications. Under current law, plan participants may no longer use funds from these accounts to purchase OTC medications, unless they have a prescription for the medication.

November 6, 2013

State legislators in Michigan are considering a bill that would allow pharmacies to sell medical marijuana, according to published reports.

NEW YORK — State legislators in Michigan are considering a bill that would allow pharmacies to sell medical marijuana, according to published reports.

November 5, 2013

The Food and Drug Administration has approved a generic injectable antibiotic drug made by Emcure Pharmaceuticals, according to the agency.

SILVER SPRING, Md. – The Food and Drug Administration has approved a generic injectable antibiotic drug made by Emcure Pharmaceuticals, according to the agency.

The FDA approved Emcure's vancomycin hydrochloride injection in the 5-g-per-vial strength.

The drug is a generic version of Vancocin, made by ViroPharma.

 

November 5, 2013

The Food and Drug Administration has approved a generic drug made by Mylan for treating overactive bladder, according to agency records.

SILVER SPRING, Md. — The Food and Drug Administration has approved a generic drug made by Mylan for treating overactive bladder, according to agency records.

The FDA approved Mylan's tolterodine tartrate extended-release capsules in the 2-mg and 4-mg strengths.

The drug is a generic version of Pfizer's Detrol LA. Detrol LA has annual sales of about $700 million, according to published reports.

 

November 4, 2013

The Food and Drug Administration has approved a new injectable painkiller made by Becton, Dickinson and Co., the medical products manufacturer said Monday.

FRANKLIN LAKES, N.J. — The Food and Drug Administration has approved a new injectable painkiller made by Becton, Dickinson and Co., the medical products manufacturer said Monday.

BD announced the FDA approval of morphine sulfate injection as part of its BD Simplist line of ready-to-administer pre-filled injectables. The drug was approved in the 2-mg-per-mL, 4-mg-per-mL, 5-mg-per-mL, 8-mg-per-mL and 10-mg-per-mL strengths.

November 4, 2013

The Food and Drug Administration has asked Ariad Pharmaceuticals to suspend marketing and sales of a chemotherapy drug for leukemia due to the risk of life-threatening side effects, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has asked Ariad Pharmaceuticals to suspend marketing and sales of a chemotherapy drug for leukemia due to the risk of life-threatening side effects, the agency said.

November 4, 2013

Perrigo on Friday initiated a voluntary, nationwide product recall to the retail level of 18 batches of its acetaminophen infant suspension liquid.

ALLEGAN, Mich. —  Perrigo on Friday initiated a voluntary, nationwide product recall to the retail level of 18 batches of its acetaminophen infant suspension liquid, 160 mg/5 mL, sold in 2 oz. and 4 oz. bottles with syringes in a box because of the remote potential that a small number of packages might contain an oral dosing syringe without dose markings. 

November 4, 2013

A proposal by the Texas State Board of Pharmacy to eliminate the required ratio of pharmacy technicians to pharmacists in retail pharmacies in the state has drawn mixed responses from professional and industry trade groups.

NEW YORK — A proposal by the Texas State Board of Pharmacy to eliminate the required ratio of pharmacy technicians to pharmacists in retail pharmacies in the state has drawn mixed responses from professional and industry trade groups.

Currently, the required ratio is three technicians to one pharmacist, which the board's proposal would remove for retail pharmacies, known under Texas law as "Class A" pharmacies. In response, the Texas Pharmacy Association has proposed an interim ratio requirement of four technicians to one pharmacist.

November 4, 2013

Drug maker UCB is seeking approval for one of its drugs as a standalone therapy for epilepsy.

ATLANTA — Drug maker UCB is seeking approval for one of its drugs as a stand-alone therapy for epilepsy.

The company said Monday that the Food and Drug Administration had accepted its regulatory approval application for Vimpat (lacosamide) for adult epilepsy patients with partial-onset seizures. The drug is already approved as an add-on therapy for partial-onset seizures in patients aged 17 and older.

November 1, 2013

The Food and Drug Administration has approved a new drug for leukemia made by Genentech, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for leukemia made by Genentech, the agency said Friday.

The FDA announced the approval of Gazyva (obinutuzumab) for treating patients with previously untreated chronic lymphocytic leukemia, in combination with the chemotherapy drug chlorambucil. The drug works by helping certain cells in the immune system attack cancer cells.

November 1, 2013

The Food and Drug Administration has approved two new insulin pens made by Novo Nordisk, the Danish drug maker said Friday.

PLAINSBORO, N.J. — The Food and Drug Administration has approved two new insulin pens made by Novo Nordisk, the Danish drug maker said Friday.

Novo Nordisk announced the FDA approval of Novolog FlexTouch (insulin aspart [rDNA origin]) and Levemir FlexTouch (insulin detemir [rDNA origin]).

November 1, 2013

Mylan expects to be the first to market with a generic version of a drug for treating patients with gout, the company said Friday, though its filing has triggered a lawsuit from the makers of the branded version.

PITTSBURGH — Mylan expects to be the first to market with a generic version of a drug for treating patients with gout, the company said Friday, though its filing has triggered a lawsuit from the makers of the branded version.

November 1, 2013

The Food and Drug Administration has released a new video that warns consumers against buying drugs from rogue-internet pharmacies, part of the ongoing effort by the agency to keep fake and contaminated drugs out of the U.S. supply chain.

NEW YORK — The Food and Drug Administration has released a new video that warns consumers against buying drugs from rogue-internet pharmacies, part of the ongoing effort by the agency to keep fake and contaminated drugs out of the U.S. supply chain.

November 1, 2013

Medication safety and pharmacy information systems get more attention in the latest version of an exam for pharmacy technicians.

WASHINGTON — Medication safety and pharmacy information systems get more attention in the latest version of an exam for pharmacy technicians.

The Pharmacy Technician Certification Board announced Friday updates to the Pharmacy Technician Certification Exam, based on the group's Job Analysis Study, which involves more than 25,000 pharmacy technicians from across the country and from different practice settings. The updated exam has nine knowledge groups known as domains, rather than three.

October 31, 2013

Actavis is seeking Food and Drug Administration approval for a generic drug used to treat acne, triggering a lawsuit in a federal court from the maker of the branded version, the company said Thursday.

DUBLIN — Actavis is seeking Food and Drug Administration approval for a generic drug used to treat acne, triggering a lawsuit in a federal court from the maker of the branded version, the company said Thursday.

The drug maker said it had filed with the FDA for approval of isotretinoin capsules in the 10-mg, 20-mg, 30-mg and 40-mg strengths. The drug is a generic version of Ranbaxy's Absorica, a retinoid used to treat severe, recalcitrant nodular acne in patients 12 and older.

October 31, 2013

A new book from a trade group representing makers of dietary supplements details the laws and regulations that govern the industry.

WASHINGTON — A new book from a trade group representing makers of dietary supplements details the laws and regulations that govern the industry.

October 31, 2013

The Food and Drug Administration is using long-term strategies to address drug shortages when they appear and requiring manufacturers to notify the agency if a shortage is at risk of happening, under a new plan announced Thursday.

SILVER SPRING, Md. — The Food and Drug Administration is using long-term strategies to address drug shortages when they appear and requiring manufacturers to notify the agency if a shortage is at risk of happening, under a new plan announced Thursday.

October 31, 2013

Earlier this year, the Food and Drug Administration approved a new drug for treating cystic fibrosis for patients who have a specific genetic mutation, but that also treats the underlying cause of the disease rather than the disease itself.

SILVER SPRINGS, Md. — Earlier this year, the Food and Drug Administration approved a new drug for treating cystic fibrosis for patients who have a specific genetic mutation, but that also treats the underlying cause of the disease rather than the disease itself.