Content about Regulatory and Washington

March 26, 2012

The U.S. Supreme Court justices have gathered this week to discuss a potential legal issue surrounding President Obama's healthcare law.

WASHINGTON — The U.S. Supreme Court justices have gathered this week to discuss a potential legal issue surrounding President Obama's healthcare law.

March 23, 2012

The Consumer Healthcare Products Association and the other members of the Health Choices Coalition on Friday sent letters to members of Congress urging the repeal of the requirement that prevents consumers from using their flexible spending arrangements to purchase over-the-counter medicines without first getting a doctor’s prescription.

WASHINGTON — The Consumer Healthcare Products Association and the other members of the Health Choices Coalition on Friday sent letters to members of Congress urging the repeal of the requirement that prevents consumers from using their flexible spending arrangements to purchase over-the-counter medicines without first getting a doctor’s prescription. 

March 23, 2012

The National Retail Federation has appointed a new VP communications.

WASHINGTON — The National Retail Federation has appointed a new VP communications.

Effective Apr. 9, Katie Wilson will be responsible for overseeing NRF’s industry efforts, a multitude of communication vehicles and advancing NRF advocacy priorities on issues important to the retail community, NRF said. She will assume many of the responsibilities of Ellen Davis, who was recently named NRF SVP and executive director of the NRF Foundation.

March 23, 2012

Lawmakers are going after companies that they say have sought to take advantage of drug shortages by buying drugs in short supply and then reselling them at higher prices, according to published reports.

NEW YORK — Lawmakers are going after companies that they say have sought to take advantage of drug shortages by buying drugs in short supply and then reselling them at higher prices, according to published reports.

March 22, 2012

The Food and Drug Administration's director of the Center for Drug Evaluation and Research, Janet Woodcock, on Thursday identified three tools the agency wanted to use in potentially increasing access to appropriate medicines in her opening remarks at the FDA Rx-to-OTC Switch Hearing.

SILVER SPRING, Md. — The Food and Drug Administration's director of the Center for Drug Evaluation and Research, Janet Woodcock, on Thursday identified three tools the agency wanted to use in potentially increasing access to appropriate medicines in her opening remarks at the FDA Rx-to-OTC Switch Hearing held here.

March 22, 2012

The Food Marketing Institute on Thursday named Hannah Walker director of government relations to represent food retailers on Capitol Hill.

ARLINGTON, Va. — The Food Marketing Institute on Thursday named Hannah Walker director of government relations to represent food retailers on Capitol Hill.

March 22, 2012

GlaxoSmithKline on Thursday morning presented exactly how technology might improve appropriate patient self-selection before a panel convened by the Food and Drug Administration to explore expanding the prescripton-to-over-the-counter switch paradigm by incorporating technology and/or pharmacy participation in the application process.

SILVER SPRING, Md. — GlaxoSmithKline on Thursday morning presented exactly how technology might improve appropriate patient self-selection before a panel convened by the Food and Drug Administration to explore expanding the prescripton-to-over-the-counter switch paradigm by incorporating technology and/or pharmacy participation in the application process.

March 22, 2012

NACDS RxImpact Day on Capitol Hill showcased the unsurpassed value of community pharmacy as pharmacy advocates from 41 states conducted more than 350 meetings with U.S. senators and representatives this week.

ALEXANDRIA, Va. — NACDS RxImpact Day on Capitol Hill showcased the unsurpassed value of community pharmacy as pharmacy advocates from 41 states conducted more than 350 meetings with U.S. senators and representatives this week.

Community pharmacy advocates — including pharmacists, pharmacy students and other pharmacy supporters — met with 86% of members of Congress who serve on congressional committees with jurisdiction on healthcare issues.

March 21, 2012

A Food and Drug Administration expert panel delivered a favorable vote on a cancer drug made by GlaxoSmithKline.

PHILADELPHIA — A Food and Drug Administration expert panel delivered a favorable vote on a cancer drug made by GlaxoSmithKline.

GSK announced that the FDA Oncologic Drugs Advisory Committee voted 11-2 that clinical trial data indicated a favorable risk-benefit profile of the drug Votrient (pazopanib) in patients with advanced soft-tissue sarcoma who have received chemotherapy. The drug is already approved for treating the kidney cancer renal cell carcinoma.

March 21, 2012

The Food and Drug Administration has approved Watson's generic version of a drug used to prevent and treat osteoporosis in post-menopausal women, the company said.

PARSIPPANY, N.J. — The Food and Drug Administration has approved Watson's generic version of a drug used to prevent and treat osteoporosis in post-menopausal women, the company said.

Watson announced the FDA's approval of ibandronate tablets in the 150-mg strength, a generic version of Genentech's Boniva. Watson plans to launch its version in second quarter 2012.

March 21, 2012

Industry-supported legislation designed to improve pharmacy benefits manager standards under the Medicare prescription drug program — standards that will further provide fair audits of and payments to pharmacies — was presented before the House of Representatives on Tuesday.

WASHINGTON — Industry-supported legislation designed to improve pharmacy benefits manager standards under the Medicare prescription drug program — standards that will further provide fair audits of and payments to pharmacies — was presented before the House of Representatives on Tuesday.

March 21, 2012

In anticipation of hundreds of meetings between pharmacy advocates and members of Congress and their staff as part of NACDS RxImpact Day on Capitol Hill, the National Association of Chain Drug Stores sent a letter to Rep. Cathy McMorris Rodgers, R-Wash., applauding the introduction of her legislation on Tuesday that would establish Medicare standards for pharmacy audits and reimbursement by pharmacy benefit managers.

ALEXANDRIA, Va. — In anticipation of hundreds of meetings between pharmacy advocates and members of Congress and their staff as part of NACDS RxImpact Day on Capitol Hill, the National Association of Chain Drug Stores sent a letter to Rep. Cathy McMorris Rodgers, R-Wash., applauding the introduction of her legislation on Tuesday that would establish Medicare standards for pharmacy audits and reimbursement by pharmacy benefit managers.

March 21, 2012

The National Retail Federation has named Ellen Davis SVP and executive director of the NRF Foundation, the education and research arm of NRF.

WASHINGTON — The National Retail Federation has named Ellen Davis SVP and executive director of the NRF Foundation, the education and research arm of NRF.

March 20, 2012

Safeway on Tuesday joined forces with the U.S. Department of Agriculture's Center for Nutrition Policy and Promotion on an initiative to develop and promote dietary guidance that links scientific research to the nutrition needs of consumers.

PLEASANTON, Calif. — Safeway on Tuesday joined forces with the U.S. Department of Agriculture's Center for Nutrition Policy and Promotion on an initiative to develop and promote dietary guidance that links scientific research to the nutrition needs of consumers.

March 19, 2012

More than 5.1 million seniors and people with disabilities on Medicare saved billions on prescription drugs, thanks to the Patient Protection and Affordable Care Act, according to Department of Health and Human Services secretary Kathleen Sebelius.

WASHINGTON — More than 5.1 million seniors and people with disabilities on Medicare saved billions on prescription drugs, thanks to the Patient Protection and Affordable Care Act, according to Department of Health and Human Services secretary Kathleen Sebelius.

New data found that these individuals saved more than $3.2 billion on prescription drugs, while savings for seniors included a one-time $250 rebate check to those who hit the "donut hole" coverage gap in 2010 and a 50% discount on covered brand-name drugs in the donut hole in 2011.

March 19, 2012

Cardinal Health's appeal to delay a Drug Enforcement Agency suspension of its license to distribute controlled substances out of its Lakeland, Fla., distribution center was denied Friday by the U.S. Court of Appeals for the District of Columbia Circuit.

WASHINGTON — Cardinal Health's appeal to delay a Drug Enforcement Agency suspension of its license to distribute controlled substances out of its Lakeland, Fla., distribution center was denied Friday by the U.S. Court of Appeals for the District of Columbia Circuit. The ruling lifts a previously granted emergency stay issued by the appellate court earlier this month.

March 19, 2012

The Food and Drug Administration has approved the first generic version of a drug for treating and preventing osteoporosis in women after menopause, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved the first generic version of a drug for treating and preventing osteoporosis in women after menopause, the agency said Monday.

The FDA announced the approval of ibandronate tablets in the 150-mg strength made by Apotex, Orchid Healthcare and Mylan Pharmaceuticals. Genentech makes the branded version of the drug.

March 19, 2012

The National Community Pharmacists Association has applauded a member of its organization for participating in the organization's drug disposal program.

ALEXANDRIA, Va. — The National Community Pharmacists Association has applauded a member of its organization for participating in the organization's drug disposal program.

March 19, 2012

Watson Pharmaceuticals is challenging the patent protection on a drug made by Abbott for treating cholesterol, the company said.

PARSIPPANY, N.J. — Watson Pharmaceuticals is challenging the patent protection on a drug made by Abbott for treating cholesterol, the company said.

Watson, through a subsidiary, filed with the Food and Drug Administration for approval of niacin extended-release tablets in the 500-mg and 1,000-mg strengths. The drug is a generic version of Abbott's Niaspan.

March 16, 2012

Another generic drug maker has joined efforts to challenge the patent on a drug made by Forest Labs for treating hypertension.

NEW YORK — Another generic drug maker has joined efforts to challenge the patent on a drug made by Forest Labs for treating hypertension.

March 16, 2012

The National Association of Chain Drug Stores is praising lawmakers in Medco Health Solutions’ home state of New Jersey for delivering what NACDS called “a bold and revealing blow” to the PBM’s proposed merger with Express Scripts.

ALEXANDRIA, Va. — The National Association of Chain Drug Stores is praising lawmakers in Medco Health Solutions’ home state of New Jersey for delivering what NACDS called “a bold and revealing blow” to the PBM’s proposed merger with Express Scripts.

March 15, 2012

The Food and Drug Administration has approved a drug that the manufacturer called the first oral contraceptive that also treats heavy menstrual bleeding.

WAYNE, N.J. — The Food and Drug Administration has approved a drug that the manufacturer called the first oral contraceptive that also treats heavy menstrual bleeding.

Bayer HealthCare Pharmaceuticals announced Wednesday the approval of Natazia (estradiol valerate and estradiol valerate and dienogest) tablets for heavy menstrual bleeding not caused by any conditions of the uterus. The drug was originally approved as an oral contraceptive in May 2010.

March 15, 2012

The Food and Drug Administration approved an effervescent tablet for treating osteoporosis.

FREIENBACH, Switzerland — The Food and Drug Administration approved an effervescent tablet for treating osteoporosis.

EffRx Pharmaceuticals announced the FDA approval of Binosto (alendronate sodium), a strawberry-flavored tablet designed to dissolve in water that the company called the first treatment of its kind. The drug is designed to treat osteoporosis in menopausal women and increase bone mass in men with osteoporosis. EffRx expects to launch Binosto in third quarter 2012.

March 14, 2012

Endo Pharmaceuticals is hoping the Food and Drug Administration will back tougher regulatory approval requirements for generic versions of one of its drugs.

CHADDS FORD, Pa. — Endo Pharmaceuticals is hoping the Food and Drug Administration will back tougher regulatory approval requirements for generic versions of one of its drugs.

March 14, 2012

The Food and Drug Administration has approved the first generic version of an antidepressant made by Forest Labs, the agency said Wednesday.

SILVER SPRINGS, Md. — The Food and Drug Administration has approved the first generic version of an antidepressant made by Forest Labs, the agency said Wednesday.

The FDA announced the approval of a generic version of Lexapro (escitalopram) made by Teva Pharmaceutical Industries in the 5-mg, 10-mg and 20-mg strengths. The drug is used to treat depression and generalized anxiety disorder in adults.