Content about Regulatory and Washington

February 11, 2011
FDA approves test to monitor levels of Zortress in the bloodstream

The Food and Drug Administration announced Friday the approval of Waltham, Mass.-based Thermo Fisher’s QMS Everolimus Immunoassay, a test that monitors the blood for levels of Novartis’ drug Zortress (everolimus).

February 11, 2011
FSA restrictions first piece of ObamaCare to be challenged

Recent restrictions imposed on flexible spending accounts appear to be the first piece of ObamaCare to be challenged by the new Congress.

February 11, 2011
IRS reclassifies breast-feeding as medical expenditure

The Internal Revenue Service on Thursday reversed itself in announcing that breast-feeding supplies qualify as a medical expense.

February 11, 2011
Makena receives FDA approval

The Food and Drug Administration has approved a drug for preventing preterm births.

February 11, 2011
Mallinckrodt receives FDA approval for generic Duragesic

The Food and Drug Administration has approved a painkiller delivered through a skin patch made by Mallinckrodt, the generic drug maker said Friday.

February 11, 2011
NACDS to House committee: More focus on patients, less on paperwork

In a statement submitted to the House of Representatives Small Business Committee, the National Association of Chain Drug Stores further emphasized its support of legislation to repeal the 1099 business tax form reporting requirements.

February 11, 2011
NCPA backs Patients’ Freedom to Choose Act

The National Community Pharmacists Association has expressed support of legislation that seeks to overturn two provisions in the Obama healthcare law that limit a patient’s choice in how to use consumer-directed health savings plans.

February 11, 2011
Report: Teva seeks approval to market Plan B One-Step for females under 17 years

Teva earlier this week announced it had submitted a request to the Food and Drug Administration to allow for the sale of the emergency contraceptive Plan B One-Step to women under the age of 17 years without a prescription, according to published reports.

February 10, 2011
Actavis OKed to market generic Protonix

Actavis has received approval from the Food and Drug Administration to market a generic version of a popular gastroesophageal reflux disease treatment.

February 10, 2011
Court: Watson's generic OTC decongestant does not infringe on branded versions

Over-the-counter generic versions of a line of products used to treat congestion do not infringe on the patents covering the branded versions, a federal court ruled Wednesday.

February 10, 2011
FDA reconsiders safety of OSP use for bowel cleansing as an OTC indication

The Food and Drug Administration will propose an amendment to the over-the-counter laxative monograph that sodium phosphate salts are not generally recognized as safe for bowel cleansing.

February 10, 2011
NACDS expresses support of The Patients' Freedom to Choose Act of 2011

Companion legislation, which seeks to change a provision in the healthcare-reform law and permit Americans to use their flexible spending accounts and health savings accounts to buy over-the-counter medications without a prescription, has the support of the National Association of Chain Drug Stores.

February 9, 2011
HHS secretary announced $750 million investment in prevention, public health

Department of Health and Human Services secretary Kathleen Sebelius on Wednesday announced a $750 million investment in prevention and public health, funded through the Prevention and Public Health Fund created by the new healthcare law.

February 9, 2011
Pharmavite’s GreatMind claims vetted by NAD

The National Advertising Division of the Council of Better Business Bureaus on Wednesday announced that Pharmavite is able to support advertising claims for the company’s NatureMade GreatMind dietary supplement, pursuant to NAD’s ongoing monitoring of advertising for dietary supplements.

February 8, 2011
NAD turns Iceberg Labs over to federal regulators regarding Immune Shield claims

The National Advertising Division of the Council of Better Business Bureaus on Tuesday referred advertising claims made by Iceberg Labs for its Immune Shield dietary supplement to the Federal Trade Commission and Food and Drug Administration for further review.

February 8, 2011
PCMA: Sebelius should continue push for cost cuts among state Medicaid programs

A group representing the nation’s pharmacy benefit managers said Health and Human Services secretary Kathleen Sebelius should continue encouraging state Medicaid programs to explore affordable pharmacy solutions despite opposition from the independent drug store lobby.

February 8, 2011
Vascugel granted fast-track designation by FDA

The Food and Drug Administration has given expedited review to a drug for preventing hemodialysis failure in patients with end-stage kidney disease.

February 7, 2011
At NACDS conference, Merlo and Anderson note pharmacy victories

Pharmacy's role in the U.S. healthcare system has expanded dramatically over the past two years, thanks to several victories gained through pharmacy care and services.

February 7, 2011
FDA approves Hospira's generic Hycamtin

The Food and Drug Administration has approved a generic cancer drug from Hospira.

February 7, 2011
NACDS reaches out to Sebelius about state Medicaid program expansion

Shortly after Health and Human Services secretary Kathleen Sebelius reached out to state governors about extending their Medicaid programs, the National Association of Chain Drug Stores sent a letter to Sebelius emphasizing the importance of expanding patient access to prescription drugs and pharmacy services to cut healthcare costs and improve patient outcomes.

February 4, 2011
CHPA names new director of federal affairs

The Consumer Healthcare Products Association on Friday named Vera Grill director of federal affairs, effective Feb. 8. In this capacity, Grill will coordinate and manage CHPA’s federal priorities, the association stated.

February 4, 2011
Elite granted FDA approval for generic Adipex-P

The Food and Drug Administration has approved a generic weight-loss drug made by Elite Pharmaceuticals.

February 4, 2011
MTM could take chunk out of the $290 billion in annual healthcare costs

Sen. Kay Hagan, D-N.C., argued before the Senate Thursday around the value that increased access to medication therapy management can deliver to overall health care — that includes cutting into the $290 billion in annual costs associated with medication nonadherence and preventing as many as 89,000 premature deaths.

February 4, 2011
Sun's generic Razadyne ER granted regulatory approval

The Food and Drug Administration has approved a generic Alzheimer’s disease treatment from Sun Pharmaceutical Industries.

February 4, 2011
Tennessee legislators have PSE choice between NPLEx and Rx-only

Tennessee may be the next state to adopt an electronic tracking tool to enforce pseudoephedrine sales restrictions and combat methamphetamine production in real time.

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