Content about Regulatory and Washington

May 6, 2013

The Food and Drug Administration may soon find itself in another Plan-B-generated quandary — the complications around granting a three-year marketing exclusivity for a medicine that is both prescription-only and over-the-counter, according to an FDA Law Blog posted Sunday by Hyman, Phelps & McNamara.

WASHINGTON — The Food and Drug Administration may soon find itself in another Plan-B-generated quandary — the complications around granting a three-year marketing exclusivity for a medicine that is both prescription-only and over-the-counter, according to an FDA Law Blog posted Sunday by Hyman, Phelps & McNamara

May 6, 2013

Florida's state legislature approved a bill last week that will allow pharmacists to substitute biosimilars for brand name biotech drugs.

NEW YORK — Florida's state legislature approved a bill last week that will allow pharmacists to substitute biosimilars for brand name biotech drugs.

The bill, which was approved last Tuesday and is scheduled to take effect on July 1, institutes requirements for pharmacists to substitute biosimilars when they are determined to be biosimilar to and interchangeable with the brand name product, while also requiring the state board of pharmacy to maintain a current list of interchangeable products.

May 6, 2013

The five associations representing the dietary supplement industry on Monday requested that the Food and Drug Administration issue revised guidance on new dietary ingredient notifications, with a specific focus on the information to be included to identify the new dietary ingredient.

SILVER SPRING, Md. — The five associations representing the dietary supplement industry on Monday requested that the Food and Drug Administration issue revised guidance on new dietary ingredient notifications, with a specific focus on the information to be included to identify the new dietary ingredient. 

May 6, 2013

Retail pharmacies, drug makers and law enforcement have a variety of methods used to fight organized crime, and the New Jersey Office of the Attorney General has drawn up a list of best practices that pharmacies can use to keep stores, drugs, staff and customers safe.

NEW YORK — Retail pharmacies, drug makers and law enforcement have a variety of methods used to fight organized crime, and the New Jersey Office of the Attorney General has drawn up a list of best practices that pharmacies can use to keep stores, drugs, staff and customers safe.

May 6, 2013

Pregnant women should not use migraine-prevention medications containing valproate sodium due to a higher risk of decreased IQ scores in children, the Food and Drug Administration warned.

SILVER SPRING, Md. — Pregnant women should not use migraine-prevention medications containing valproate sodium due to a higher risk of decreased IQ scores in children, the Food and Drug Administration warned Monday.

In addition to being used to prevent migraines, valproate drugs are used for treating epilepsy and bipolar disorder and include related drugs such as divalproex sodium and valproic acid. Most are available in generic form as well as under brand names like AbbVie's Depacon and Depakote and others.

May 3, 2013

Only 1-in-5 U.S. adults are meeting both the aerobic and muscle strengthening components of the federal government's physical activity recommendations, according to an article published Thursday in Morbidity and Mortality Weekly Report, a journal of the Centers for Disease Control and Prevention.

ATLANTA — Only 1-in-5 U.S. adults are meeting both the aerobic and muscle strengthening components of the federal government's physical activity recommendations, according to an article published Thursday in Morbidity and Mortality Weekly Report, a journal of the Centers for Disease Control and Prevention.

May 3, 2013

The National Community Pharmacists Association on Thursday urged Hawaii Gov. Neil Abercrombie to sign two bills into law that the association asserts will "protect patient pharmacy choice."

ALEXANDRIA, Va. — The National Community Pharmacists Association on Thursday urged Hawaii Gov.

May 3, 2013

The retail industry added nearly 30,000 jobs last month amid a general uptick in hiring that brought unemployment down to 7.5%, according to the Department of Labor.

WASHINGTON — The retail industry added nearly 30,000 jobs last month amid a general uptick in hiring that brought unemployment down to 7.5%, according to the Department of Labor.

The department's monthly jobs report showed the economy added 165,000 jobs, including 29,000 in the retail industry, which accounts for the largest number of private sector jobs. In addition, the March jobs report, which initially showed that the economy added only 88,000 jobs, was revised upward to 138,000, while the February report was revised upward to 332,000.

May 2, 2013

The Justice Department reported it will appeal a recent judicial decision that would require removing any age restriction from the purchase of the Plan B emergency contraceptive, according to a report published in USA Today.

WASHINGTON — The Justice Department late Wednesday reported it will appeal a recent judicial decision that would require removing any age restriction from the purchase of the Plan B emergency contraceptive, according to a report published in USA Today.

May 1, 2013

The Food and Drug Administration announced that it has approved an amended application submitted by Teva Women’s Health to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years and older.

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday announced that it has approved an amended application submitted by Teva Women’s Health to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years and older. The approval will move Plan B from behind the pharmacy counter into the family planning set of the pharmacy. 

April 30, 2013

The Food and Drug Administration has approved two generic drugs made by Aurobindo Pharma, the drug maker said.

HYDERABAD — The Food and Drug Administration has approved two generic drugs made by Aurobindo Pharma, the drug maker said.

The company announced Tuesday the approval of quinapril tablets in the 5-mg, 10-mg, 20-mg and 40-mg strengths. The drug is a generic version of Pfizer's Accupril and is used to treat high blood pressure. Various versions of the drug had sales of about $49 million during the 12-month period ending in September, according to IMS Health.

April 30, 2013

The Food and Drug Administration has approved a new treatment for a genetic disorder that affects about 500 people in the United States and 3,000 worldwide, the agency said Tuesday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for a genetic disorder that affects about 500 people in the United States and 3,000 worldwide, the agency said Tuesday.

April 30, 2013

The Food and Drug Administration has approved a drug that reverses the effects of anticoagulant drugs in patients who have suffered acute major bleeding, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug that reverses the effects of anticoagulant drugs in patients who have suffered acute major bleeding, the agency said.

The FDA announced the approval of CSL Behring's Kcentra (prothrombin complex concentrate [human]) for the urgent reversal of vitamin K antagonist, or VKA drugs such as warfarin.

April 30, 2013

The Food and Drug Administration has approved a drug made by Genentech for a rare form of arthritis in children, the company said Tuesday.

SOUTH SAN FRANCISCO, Calif. — The Food and Drug Administration has approved a drug made by Genentech for a rare form of arthritis in children, the company said Tuesday.

Genentech, a subsidiary of Swiss drug maker Roche, announced the approval of Actemra (tocilizumab) for polyarticular juvenile idiopathic arthritis in children ages 2 years and older, either alone or combined with the generic drug methotrexate.

April 30, 2013

The Food and Drug Administration declined to approve two drugs for HIV made by Gilead Sciences for which the company was seeking approval for use as part of treatment regimens.

FOSTER CITY, Calif. — The Food and Drug Administration declined to approve two drugs for HIV made by Gilead Sciences for which the company was seeking approval for use as part of treatment regimens.

April 29, 2013

Consumer Reports recently corrected a story to run in its May issue, titled “Vitamin D: How 32 supplements really measure up," that erroneously identified nine vitamin D/calcium supplement products that the publication claimed exceeded the California Proposition 65 Lead Limit for Reproductive Risk.

WASHINGTON — Consumer Reports recently corrected a story to run in its May issue, titled “Vitamin D: How 32 supplements really measure up," that erroneously identified nine vitamin D/calcium supplement products that the publication claimed exceeded the California Proposition 65 Lead Limit for Reproductive Risk.

April 29, 2013

A Food and Drug Administration staffer who has led implementation of the Generic Drug User Fee Act has been named to a new director position at the agency, the FDA said Monday.

SILVER SPRING, Md. — A Food and Drug Administration staffer who has led implementation of the Generic Drug User Fee Act has been named to a new director position at the agency, the FDA said Monday.

The FDA announced that it had appointed Mary Beth Clarke as permanent director of the Office of Executive Programs. Clarke had previously served as the OEP's executive director.

April 29, 2013

Electronic health platform Fitango is creating a three-part action plan to support childhood immunizations, the company said.

NEW YORK — Electronic health platform Fitango is creating a three-part action plan to support childhood immunizations, the company said Monday.

Fitango announced the release of its new series of Preventative Actionplans, broken up according to age, respectively titled "Tracking Your Child's Vaccinations (0 - 2)," "Tracking Your Child's Vaccinations (4 - 6)" and "Tracking Your Child's Vaccinations (7 - 18)."

April 29, 2013

The National Advertising Division last week recommended that Interhealth Nutraceuticals discontinue certain claims for the company’s Zychrome dietary supplements, products that are promoted for the management of insulin levels.

NEW YORK — The National Advertising Division last week recommended that Interhealth Nutraceuticals discontinue certain claims for the company’s Zychrome dietary supplements, products that are promoted for the management of insulin levels.

Print and internet claims made by Interhealth for its Zychrome chromium compound, also known as chromium dinicocysteinate, were challenged by Nutrition 21, the manufacturer of a competing product, Chromax, a chromium picolinate product. Interhealth had been making comparison claims against the supplement ingredient in Chromax. 

April 26, 2013

Generic drug maker Actavis is settling a patent-infringement suit with Purdue Pharma concerning the opioid painkiller OxyContin, Actavis said, saying it expected to make more than $100 million in the deal between 2014 and 2015.

PARSIPPANY, N.J. — Generic drug maker Actavis is settling a patent-infringement suit with Purdue Pharma concerning the opioid painkiller OxyContin, Actavis said Friday, saying it expected to make more than $100 million in the deal between 2014 and 2015.

April 26, 2013

More than 1.3 million emergency room visits in 2010 were related to abuse of prescription drugs, and the problem has become widespread enough that the Centers for Disease Control and Prevention classifies it as an epidemic. In response, curbing abuse of prescription drugs has become a cornerstone of the Obama administration's drug policy.

WASHINGTON — More than 1.3 million emergency room visits in 2010 were related to abuse of prescription drugs, and the problem has become widespread enough that the Centers for Disease Control and Prevention classifies it as an epidemic. In response, curbing abuse of prescription drugs has become a cornerstone of the Obama administration's drug policy.

April 26, 2013

More than 200 drugs for blood cancers are under development, according to a new report by a drug industry trade group.

WASHINGTON — More than 200 drugs for blood cancers are under development, according to a new report by a drug industry trade group.

The Pharmaceutical Research and Manufacturers of America said 241 medicines were in clinical development or under review by the Food and Drug Administration, including 98 for lymphoma, 97 for leukemia, 52 for multiple myeloma and 24 for malignancies of the bone marrow, blood and lymph nodes.

April 26, 2013

The Marketplace Fairness Act is one step closer to passing. The Senate voted 63-30 to end debate on the bill, which would compel online retailers to collect state taxes, and will make a final decision on the bill on May 6.

WASHINGTON — The Marketplace Fairness Act is one step closer to passing. The Senate voted 63-30 Thursday to end debate on the bill, which would compel online retailers to collect state taxes, and will make a final decision on the bill on May 6. 

April 25, 2013

Actavis can launch a generic version of an attention deficit hyperactivity disorder drug made by Shire next year under an agreement between the two companies announced Thursday.

PARSAPPANY, N.J. — Actavis can launch a generic version of an attention deficit hyperactivity disorder drug made by Shire next year under an agreement between the two companies announced Thursday.

April 25, 2013

A coalition of consumers, businesses and pharmacists is promoting greater access to immunizations to mark World Immunization Week, which lasts from April 24 to 30.

WASHINGTON — A coalition of consumers, businesses and pharmacists is promoting greater access to immunizations to mark World Immunization Week, which started Wednesday and lasts until next Tuesday.

Pharmacy Choice and Access Now said it was encouraging states to expand the types of vaccines that pharmacists can administer.