Content about Regulatory and Washington

March 1, 2013

NACDS touts MTM in response to CMS call letter

Every year, the Centers for Medicare and Medicaid Services issues a "call letter" to lay out various policies and requirements for the coming program year within the Medicare program.

ARLINGTON, Va. — Every year, the Centers for Medicare and Medicaid Services issues a "call letter" to lay out various policies and requirements for the coming program year within the Medicare program.

March 1, 2013

PTCB to change pharmacy tech-certification program

The Pharmacy Technician Certification Board is making changes to its certification program that it said would advance pharmacy tech certifications, the group announced.

WASHINGTON — The Pharmacy Technician Certification Board is making changes to its certification program that it said would advance pharmacy tech certifications, the group announced.

The PTCB said that over the next seven years, it would phase in the changes, which include mandatory background checks, accredited education requirements and changes in acceptable continuing education programs for recertification. The group said its requirements have remained largely unchanged since its 1995 founding.

March 1, 2013

Supreme Court to hear patent settlements case

The Supreme Court will hear arguments later this month in a case that could determine the future of many patent settlements between brand and generic drug makers.

WASHINGTON — The Supreme Court will hear arguments later this month in a case that could determine the future of many patent settlements between brand and generic drug makers.

The high court will hear arguments in the case, Federal Trade Commission v. Actavis, on March 25. The case was originally titled FTC v. Watson, but has changed since Watson Pharmaceuticals changed its name following its acquisition of Swiss generic drug maker Actavis.

February 28, 2013

Awareness, use of e-cigarettes increasing rapidly, CDC study finds

The number of adult smokers who had used electronic cigarettes more than doubled in the space of a year, according to a new study by the Centers for Disease Control and Prevention.

ATLANTA — The number of adult smokers who had used electronic cigarettes more than doubled in the space of a year, according to a new study by the Centers for Disease Control and Prevention.

February 28, 2013

Battle over 'pay for delay' intensifies

The battle over "pay for delay" continues to heat up, and its resolution likely won't come until the nation's highest court decides on the legality of the practice.

February 28, 2013

FDA sets generic drug user fee rates for 2013

The Food and Drug Administration has set user fee rates for generic drug companies, the agency said Jan. 27.

SILVER SPRING, Md. — The Food and Drug Administration has set user fee rates for generic drug companies, the agency said Jan. 27.

The FDA announced that it had published a notice in the Federal Register for companies that make finished dosage forms, meaning drugs in their final form, and active pharmaceutical ingredients, meaning the main ingredients of the drugs.

February 28, 2013

NCPA provides insight on addressing waste, fraud and abuse in health care to House subcommittee

The National Community Pharmacists Association on Wednesday submitted a statement for the record to the U.S. House Energy and Commerce Health Subcommittee for its hearing on “Fostering Innovation to Fight Waste, Fraud and Abuse in Health Care.”

ALEXANDRIA, Va. — The National Community Pharmacists Association on Wednesday submitted a statement for the record to the U.S. House Energy and Commerce Health Subcommittee for its hearing on “Fostering Innovation to Fight Waste, Fraud and Abuse in Health Care.” NCPA’s statement called for pharmacy audits to focus on true waste, fraud and abuse as opposed to clerical errors, and for policymakers to examine mail-order waste in federal health programs.

February 28, 2013

NCPA supports Kentucky Senate bill for transparency of MAC pricing

The National Community Pharmacists Association applauded the Kentucky Senate for voting to pass S.B. 107, a bill that will provide transparency regarding how pharmacy reimbursements are determined for multiple source generic drugs, and establish an appeals process when a dispute arises over those payment levels.

ALEXANDRIA, Va. — The National Community Pharmacists Association on Thursday applauded the Kentucky Senate for voting to pass S.B. 107, a bill that will provide transparency regarding how pharmacy reimbursements are determined for multiple source generic drugs, and establish an appeals process when a dispute arises over those payment levels.

February 28, 2013

PBMS leverage generics as effective cost-saving tool

Pharmacy benefit managers are becoming increasingly adept at leveraging the power of generics to save client healthcare dollars and improve their own standing, reports indicated.

"The opportunity for lowering costs by promoting generics over brands has never been greater, given the unprecedented number of drugs set to lose patent protection over the next few years," noted the "2012 Towers Watson/National Business Group on Health Employer Survey on Purchasing Value in Health Care."

February 28, 2013

Senate hearing looks at delivery system reform

Medicare and Medicaid are working with the private sector to create a roadmap for the future of healthcare delivery, and a congressional hearing was convened Thursday to ensure it does that.

ARLINGTON, Va. — Medicare and Medicaid are working with the private sector to create a roadmap for the future of healthcare delivery, and a congressional hearing was convened Thursday to ensure it does that.

The Senate Finance Committee hearing, titled "Delivery System Reform: Progress Report from CMS," included Sens. Max Baucus, D-Mont., and Orrin Hatch, R-Utah.

February 27, 2013

ERSP advises Lunada Biomedical to discontinue weight-loss claims for supplement Amberen

The Electronic Retailing Self-Regulation Program on Monday recommended that Lunada Biomedical discontinue weight-loss and other claims made for Amberen, a dietary supplement marketed to menopausal women.

NEW YORK — The Electronic Retailing Self-Regulation Program on Monday recommended that Lunada Biomedical discontinue weight-loss and other claims made for Amberen, a dietary supplement marketed to menopausal women. ERSP found, however, the company could support claims related to hot flashes, irritability, sleeplessness and “low libido.”

February 27, 2013

House calls for GAO review of pending diabetes supply reimbursement changes

The National Community Pharmacists Association on Wednesday commended a bipartisan push for the Government Accountability Office to review the impact on patients of sharp reductions in reimbursement for diabetes test supplies provided by community pharmacies to Medicare beneficiaries.

ALEXANDRIA, Va. — The National Community Pharmacists Association on Wednesday commended a bipartisan push for the Government Accountability Office to review the impact on patients of sharp reductions in reimbursement for diabetes test supplies provided by community pharmacies to Medicare beneficiaries.

February 26, 2013

C. Everett Koop, surgeon general during Reagan era, dies

Former surgeon general C. Everett Koop died Monday. He was 96.

WASHINGTON — Former surgeon general C. Everett Koop died Monday. He was 96.

Koop, who served as surgeon general from January 1982 to October 1989, was outspoken about the damaging health effects of smoking and also an early advocate of educating Americans about AIDS. In 1988, he released "Understanding AIDS," a U.S. Public Health Service brochure based on Centers for Disease Control and Prevention guidelines, which was sent to 107 million households.

February 26, 2013

FDA approves drug for pain during sex due to menopause

The Food and Drug Administration has approved a drug for postmenopausal women who experience pain during sex.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug for postmenopausal women who experience pain during sex.

The agency announced the approval of Shionogi's Osphena (ospemifene) for women with moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause associated with declining levels of estrogen hormones.

February 26, 2013

NCPA study finds 90-day scripts at retail delivered at lower cost than mail-order

A newly conducted study of millions of Medicare Part D prescription drug event data has found that community pharmacies provide 90-day medication supplies at lower cost than mail-order pharmacies and that local pharmacists substitute lower-cost generic drugs more often when compared with mail-order pharmacies.

ALEXANDRIA, Va. — A newly conducted study of millions of Medicare Part D prescription drug event data has found that community pharmacies provide 90-day medication supplies at lower cost than mail-order pharmacies and that local pharmacists substitute lower-cost generic drugs more often when compared with mail-order pharmacies.

February 26, 2013

Office of the National Coordinator recognizes Michigan e-prescribing effort

The federal government has recognized the state of Michigan as a national leader in electronic prescribing, a group of health organizations in the state said.

LANSING, Mich. — The federal government has recognized the state of Michigan as a national leader in electronic prescribing, a group of health organizations in the state said.

The Michigan Health Information Network said that the Office of the National Coordinator for health information technology had commended it, recognizing that 94% of pharmacies in the state are equipped for e-prescribing.

February 26, 2013

Ranbaxy resumes production of cholesterol drug ingredients

Drug maker Ranbaxy Labs has started producing the ingredients for a cholesterol drug while working with the Food and Drug Administration to fix manufacturing issues that led to the recall in November 2012 of several batches of the drug.

NEW YORK — Drug maker Ranbaxy Labs has started producing the ingredients for a cholesterol drug while working with the Food and Drug Administration to fix manufacturing issues that led to the recall in November 2012 of several batches of the drug.

The Indian drug maker said it had initiated corrective and preventive actions, or CAPA, as it prepared to resume supplies of generic atorvastatin calcium tablets to the U.S. market. The drug is a generic version of Pfizer's Lipitor, and Ranbaxy became the first company to market a generic version in November 2011.

February 26, 2013

Reports: Legislation would allow Tenn. supermarkets to sell wine

A state Senate committee in Tennessee is looking into the possibility of allowing supermarkets to sell wine, according to published reports.

NEW YORK — A state Senate committee in Tennessee is looking into the possibility of allowing supermarkets to sell wine, according to published reports.

The Memphis, Tenn., Commercial Appeal reported that the proposed law would be subject to approval in local referendums.

Supporters of the bill cited convenience, while opponents — including liquor store owners — said it would be detrimental to public health, safety and the economy, criticizing the legislation as driven by "big national chains" and harmful to locally owned businesses.

February 26, 2013

USPSTF recommendation against vitamin D, calcium supplementation draws criticism

The U.S. Preventive Services Task Force on Monday issued a trio of controversial recommendations regarding supplementing with vitamin D and calcium.

WASHINGTON — The U.S. Preventive Services Task Force on Monday issued a trio of controversial recommendations regarding supplementing with vitamin D and calcium. Specifically, the Task Force determined that the current evidence was insufficient to support vitamin D and calcium supplementation for the primary prevention of fractures in premenopausal women, in men or in postmenopausal women and recommended against daily supplementation of vitamin D or calcium toward that end.

February 25, 2013

APhA survey finds growing demand for MTM services

The American Pharmacists Association has released the latest edition of a publication for pharmacists who provide medication therapy management services, the professional group said.

WASHINGTON — The American Pharmacists Association has released the latest edition of a publication for pharmacists who provide medication therapy management services, the professional group said Monday.

February 25, 2013

As legislators push for warnings, energy drinks sales soar

The energy drink category, which has enjoyed double-digit sales and unit growth for several years, faces increasing scrutiny from the Food and Drug Administration.

The FDA has said it will consider requiring companies to disclose the amount of caffeine in the drinks and add warnings about possible side effects on labeling.

February 25, 2013

CDC: Flu incidence drops to 2.8%

The proportion of outpatient visits for influenza-like illness was 2.8% for the week ended Feb. 16, the Centers for Disease Control and Prevention reported Friday, a strong indicator that the 2012-2013 flu season is on its way out.

ATLANTA — The proportion of outpatient visits for influenza-like illness was 2.8% for the week ended Feb. 16, the Centers for Disease Control and Prevention reported Friday, a strong indicator that the 2012-2013 flu season is on its way out. Nevada, New Jersey and Vermont were still reporting high ILI activity; while 13 states and New York City reported moderate activity; 11 states reported low activity; and 23 states reported minimal activity.

February 25, 2013

FDA approves Amneal opioid-dependence drug

Amneal Pharmaceuticals has received approval from the Food and Drug Administration for a drug to treat opioid dependence.

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has received approval from the Food and Drug Administration for a drug to treat opioid dependence.

Amneal announced Monday the approval of buprenorphine hydrochloride and naloxone hydrochloride sublingual tablets, a generic version of Reckitt Benckiser Healthcare's Suboxone.

Suboxone had sales of $1.5 billion in 2012, according to IMS Health.

February 25, 2013

FDA approves Bayer's Stivarga for gastrointestinal stromal tumors

The Food and Drug Administration has approved a new drug made by Bayer HealthCare Pharmaceuticals for treating tumors of the digestive system, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by Bayer HealthCare Pharmaceuticals for treating tumors of the digestive system, the agency said Monday.

The FDA announced the approval of Stivarga (regorafenib) for gastrointestinal stromal tumors that could not be removed through surgery or had spread to other parts of the body and were no longer responding to treatment with Novartis' Gleevec (imatinib) or Pfizer's Sutent (sunitinib).

February 25, 2013

Generic tsunami eases, but leaves transformed Rx landscape in its wake

The generic drug tidal wave became a tsunami in 2012, with some of the world's top-selling pharmaceuticals swamped by generic competition, and health plan payers scrambling to reap billions of dollars in financial savings.