Content about Regulatory and Washington

November 21, 2013

Pharmacists traditionally have been one of the most underutilized members of the healthcare team, possibly because they hadn’t been officially recognized as part of that team. That, however, is about to change.

Pharmacists traditionally have been one of the most underutilized members of the healthcare team, possibly because they hadn’t been officially recognized as part of that team. That, however, is about to change.

November 20, 2013

The electronic currency known as bitcoin allows small- and medium-sized companies to reach more customers by opening new markets that were previously unreachable, the co-founder of a company that allows businesses to use bitcoins said in testimony Tuesday before two Senate subcommittees. And it appears that federal authorities are open to its development.

WASHINGTON — The electronic currency known as bitcoin allows small- and medium-sized companies to reach more customers by opening new markets that were previously unreachable, the co-founder of a company that allows businesses to use bitcoins said in testimony Tuesday before two Senate subcommittees. And it appears that federal authorities are open to its development.

November 20, 2013

Drug maker Perrigo has filed with the Food and Drug Administration for approval of a generic topical ointment for treating acne in adolescents and adults, the company said Wednesday.

ALLEGAN, Mich. — Drug maker Perrigo has filed with the Food and Drug Administration for approval of a generic topical ointment for treating acne in adolescents and adults, the company said Wednesday.

Perrigo said it filed for approval of clindamycin phosphate and benzoyl peroxide gel in the 1.2%/2.5% strengths. The drug is used to treat acne in patients 12 years and older.

November 20, 2013

More than six dozen pharmacists and pharmacy students from in and around the District of Columbia offered free health screenings on Capitol Hill Tuesday as a way to promote awareness of the role pharmacists play in the healthcare system.

WASHINGTON — More than six dozen pharmacists and pharmacy students from in and around the District of Columbia offered free health screenings on Capitol Hill Tuesday as a way to promote awareness of the role pharmacists play in the healthcare system.

November 20, 2013

Following actions by the Food and Drug Administration, USPLabs has agreed to recall and destroy the dietary supplement OxyElite Pro, as it has been linked to dozens of cases of acute liver failure and hepatitis, including one death and illnesses so severe that several patients required liver transplants, the agency noted Wednesday.

SILVER SPRING, Md. — Following actions by the Food and Drug Administration, USPLabs has agreed to recall and destroy the dietary supplement OxyElite Pro, as it has been linked to dozens of cases of acute liver failure and hepatitis, including one death and illnesses so severe that several patients required liver transplants, the agency noted Wednesday. 

November 20, 2013

Through mid-November, a national registry of over-the-counter drugs considered chemical precursors to methamphetamine prevented more than 16,700 boxes of the drugs from being sold illegally.

CHARLESTON, W.Va. — Through mid-November, a national registry of over-the-counter drugs considered chemical precursors to methamphetamine prevented more than 16,700 boxes of the drugs from being sold illegally.

November 19, 2013

SILVER SPRING, Md. — At the request of the Food and Drug Administration, U.S. Marshals seized dietary supplements manufactured and held by Hi-Tech Pharmaceuticals, located in Norcross, Ga., after FDA investigators found the products contained 1, 3-Dimethylamylamine HCl (DMAA) or its chemical equivalent, the agency announced Monday.

“This company has a responsibility to ensure its products are safe for distribution and human consumption,” stated Melinda Plaisier, the FDA’s associate commissioner for regulatory affairs. “We have taken action to protect consumers and demonstrate our commitment to their safety by keeping these products from entering the distribution system.”

The retail value of the seized products is more than $2 million, the agency estimated.

A complaint filed in the U.S. District Court for the Northern District of Georgia alleged that the products were adulterated according to the Federal Food, Drug, and Cosmetic Act because they contain DMAA, an unapproved food additive that is deemed unsafe under the law.

The FDA is urging consumers not to buy or use supplements containing DMAA, which can elevate blood pressure and could lead to cardiovascular problems, including heart attack, shortness of breath and tightening of the chest. Given the known biological activity of DMAA, the ingredient may be particularly dangerous when used with caffeine. Consumers should check labels and avoid any dietary supplements containing DMAA, which is referred to on different product labels by 10 possible names. The FDA has warned consumers about the health risks of DMAA on its web site.

On Nov. 12, 2013, U.S. Marshals seized more than 1,500 cases of finished goods and more than 1,200 pounds of in-process/raw material goods from the Hi-Tech Pharmaceuticals facility.

During the FDA’s inspection of Hi-Tech Pharmaceuticals, which began in October, investigators identified 11 products that were labeled as containing DMAA or its chemical equivalent. These products included Black Widow, ECA Xtreme, Fastin, Fastin-XR, Lipodrene, Lipodrene Hardcore, Lipodrene XR, Lipodrene Xtreme, Lipotherm, Stimerex-ES, and Yellow Scorpion. The investigators also observed bulk DMAA raw ingredients at the facility. Prior to the seizure, on Nov. 1, 2013, the FDA issued an administrative detention, temporarily holding the products until they were seized.

Dietary supplements containing DMAA are illegal and the FDA is using all available tools at its disposal to remove these products from the market. In 2012, the FDA issued warning letters to companies notifying them that products containing DMAA need to be taken off the market or reformulated to remove this substance.

SILVER SPRING, Md. — At the request of the Food and Drug Administration, U.S. Marshals seized dietary supplements manufactured and held by Hi-Tech Pharmaceuticals, located in Norcross, Ga., after FDA investigators found the products contained 1, 3-Dimethylamylamine HCl (DMAA) or its chemical equivalent, the agency announced Monday.  

November 19, 2013

A pair of Congress leaders — Reps. Doug Collins, R-Ga., and Martha Roby, R-Ala. — on Tuesday advocated for community pharmacy with letters addressed to the leaders of the House Energy and Commerce Committee and Ways and Means Committee.

ALEXANDRIA, Va. — Reps. Doug Collins, R-Ga., and Martha Roby, R-Ala., on Tuesday advocated for community pharmacy with letters addressed to the leaders of the House Energy and Commerce Committee and Ways and Means Committee. 

In serving Medicare seniors, community pharmacies should be subject to the same three-year audit review period as hospitals, and not forced to document 10-year-old claims, the Representatives suggested.  

November 18, 2013

Drug maker Actavis hopes to become the first to market with a generic version of a topical testosterone replacement drug marketed by Eli Lilly, Actavis said.

DUBLIN — Drug maker Actavis hopes to become the first to market with a generic version of a topical testosterone replacement drug marketed by Eli Lilly, Actavis said.

The generic drug maker it filed with the Food and Drug Administration for approval of testosterone topical solution in the 30-mg-per-1.5 mL strength, a generic version of Lilly's Axiron. The drug is used as a replacement therapy for deficient or absent testosterone.

November 18, 2013

The Consumer Healthcare Products Association on Friday submitted a letter to U.S. Treasury Secretary Jacob Lew, thanking the Administration for its recent efforts to enhance flexible savings arrangements’ benefits, the association announced.

WASHINGTON — The Consumer Healthcare Products Association on Friday submitted a letter to U.S. Treasury Secretary Jacob Lew, thanking the Administration for its recent efforts to enhance flexible savings arrangements’ benefits, the association announced. The association is asking the Administration to take a further step and support restoring over-the-counter medicines’ eligibility under tax-preferred accounts including FSAs and health savings accounts. 

November 18, 2013

The Environmental Protection Agency has recognized Ahold USA for its efforts to reduce food waste, the agency said.

HARRISBURG, Pa. — The Environmental Protection Agency has recognized Ahold USA for its efforts to reduce food waste, the agency said.

November 18, 2013

URAC has granted accreditation to Parkway Pharmacy, a specialty pharmacy based in New Jersey.

NEW YORK — URAC has granted accreditation to Parkway Pharmacy, a specialty pharmacy based in New Jersey.

The pharmacy said Monday that it had received URAC's full Specialty Pharmacy Accreditation. Parkway was established in 2010.

November 18, 2013

A bill that would implement federal tracking and tracing of drugs and strengthen federal regulations on pharmacy compounding has passed in the Senate and will go to President Barack Obama for his signature.

NEW YORK — A bill that would implement federal tracking and tracing of drugs and strengthen federal regulations on pharmacy compounding has passed in the Senate and will go to President Barack Obama for his signature.

November 15, 2013

A Food and Drug Administration expert panel has voted to recommend approval for a drug to treat a circadian rhythm disorder that affects most people with total blindness.

WASHINGTON — A Food and Drug Administration expert panel has voted to recommend approval for a drug to treat a circadian rhythm disorder that affects most people with total blindness.

November 15, 2013

The Food and Drug Administration has approved a new drug for fungal infections of the skin made by Valeant Pharmaceuticals International, the drug maker said Friday.

LAVAL, Quebec — The Food and Drug Administration has approved a new drug for fungal infections of the skin made by Valeant Pharmaceuticals International, the drug maker said Friday.

The company announced the FDA approval of Luzu (luliconazole) cream in the 1% strength for treatment of athlete's foot, jock itch and ringworm in adults.

November 15, 2013

The Food and Drug Administration has approved an OTC personal lubricant that helps couples conceive more easily.

CHICAGO — The Food and Drug Administration has approved an OTC personal lubricant that helps couples conceive more easily.

Sasmar announced Friday the FDA approval of Conceive Plus, described as an isotonic, fertility-friendly personal lubricant that helps increase a woman's chances of getting pregnant naturally. The patent-pending formula is pH balanced to mimic fertile fluids and semen and contains minerals helpful to fertilization.

November 15, 2013

The Food and Drug Administration has given orphan drug designation to an experimental treatment for a rare form of epilepsy.

LONDON — The Food and Drug Administration has given orphan drug designation to an experimental treatment for a rare form of epilepsy.

GW Pharmaceuticals said Friday that the FDA had granted the designation to Epidiolex for Dravet syndrome, a severe, drug-resistant form of epilepsy that begins in infancy. The drug is an oral liquid of a highly purified extract of cannabidiol, a non-psychoactive molecule derived from the cannabis plant.

November 15, 2013

The value of drugs approved in the United States this year could reach almost $19 billion in sales five years after their launch, exceeding the value of drugs approved in 2012, according to a new report.

NEW YORK — The value of drugs approved in the United States this year could reach almost $19 billion in sales five years after their launch, exceeding the value of drugs approved in 2012, according to a new report.

November 15, 2013

New cardiovascular health guidelines released this week could dampen the potential popularity of an up-and-coming class of cholesterol drugs, according to published reports.

NEW YORK — New cardiovascular health guidelines released this week could dampen the potential popularity of an up-and-coming class of cholesterol drugs, according to published reports.

November 14, 2013

The Food and Drug Administration has requested label and packaging changes of certain over-the-counter topical antiseptic products, according to an FDA MedWatch alert.

SILVER SPRING, Md. — The Food and Drug Administration has requested label and packaging changes of certain over-the-counter topical antiseptic products, according to an FDA MedWatch alert emailed Thursday. "We are requesting that manufacturers package antiseptics indicated for preoperative or preinjection skin preparation in single-use containers," the alert stated. "The antiseptics in these single-use containers should be applied only one time to one patient.

November 14, 2013

New legislation signed into law Wednesday encourages states to adopt laws allowing schools to maintain a supply of emergency treatments for life-threatening allergy attacks.

NEW YORK — New legislation signed into law Wednesday encourages states to adopt laws allowing schools to maintain a supply of emergency treatments for life-threatening allergy attacks.

Barack Obama signed the School Access to Emergency Epinephrine Act, under which schools could maintain a supply of epinephrine, which is the only first-line treatment for life-threatening allergic reactions, also known as anaphylaxis.

The legislation received praise from Mylan, a drug maker that produces EpiPen, a popular epinephrine injector pen.

November 14, 2013

Domestic violence has devastating effects on families, but new research also links it to chronic disease in women and calls on healthcare professionals to do more to determine whether there may be a link between the two in patients.

WASHINGTON — Domestic violence has devastating effects on families, but new research also links it to chronic disease in women and calls on healthcare professionals to do more to determine whether there may be a link between the two in patients.

November 13, 2013

As cold and flu season kicks into high gear, the Acetaminophen Awareness Coalition on Tuesday issued a nationwide safety message urging consumers to double-check their medicine labels so they don’t double-up on medicines that contain acetaminophen when treating winter illnesses.

WASHINGTON — As cold and flu season kicks into high gear, the Acetaminophen Awareness Coalition on Tuesday issued a nationwide safety message urging consumers to double-check their medicine labels so they don’t double-up on medicines that contain acetaminophen when treating winter illnesses. 

November 13, 2013

The Food and Drug Administration has approved a new drug for treating a rare and aggressive type of blood cancer, the agency said Wednesday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating a rare and aggressive type of blood cancer, the agency said Wednesday.

The FDA announced the approval of Imbruvica (ibrutinib), marketed by Pharmacyclics and Johnson & Johnson, for treating mantle cell lymphoma, or MCL. MCL is a rare form of non-Hodgkin lymphoma and represents about 6% of all non-Hodgkin lymphoma cases in the United States. Millennium Pharmaceuticals' Velcade (bortezomib) and Celgene's Revlimid (lenalidomide) are also approved for treating MCL.

November 13, 2013

The Food and Drug Administration has given special designation to a drug under development by Mast Therapeutics for a rare disease that restricts the flow of blood to the limbs.

SAN DIEGO — The Food and Drug Administration has given special designation to a drug under development by Mast Therapeutics for a rare disease that restricts the flow of blood to the limbs.