Content about Regulatory and Washington

December 15, 2011

The Generic Pharmaceutical Association proposed Thursday the creation of a new initiative to combat the problem of drug shortages.

WASHINGTON — The Generic Pharmaceutical Association proposed Thursday the creation of a new initiative to combat the problem of drug shortages.

December 15, 2011

The National Association of Chain Drug Stores and National Community Pharmacists Association issued a statement on Thursday announcing that they commend Reps. Bruce Braley, D-Iowa; Mike Rogers, R-Mich.; and 38 of their colleagues who expressed concerns with draft Federal Upper Limits lists that recently have been published by the Centers for Medicare and Medicaid Services.

ALEXANDRIA, Va. — The National Association of Chain Drug Stores and National Community Pharmacists Association issued a statement on Thursday announcing that they commend Reps. Bruce Braley, D-Iowa; Mike Rogers, R-Mich.; and 38 of their colleagues who expressed concerns with draft Federal Upper Limits lists that recently have been published by the Centers for Medicare and Medicaid Services.

December 15, 2011

A group of Medicine Shoppe International and Medicap franchise owners is filing claims against the two companies over an alleged breach of contract and failure to support the franchise systems.

ST. LOUIS — A group of Medicine Shoppe International and Medicap franchise owners is filing claims against the two companies over an alleged breach of contract and failure to support the franchise systems.

December 14, 2011

The Centers for Disease Control and Prevention and the Consumer Healthcare Products Association Educational Foundation on Tuesday launched the Up and Away and Out of Sight educational program to help educate parents on the importance of keeping their medicines in a safe place from children.

WASHINGTON — The Centers for Disease Control and Prevention and the Consumer Healthcare Products Association Educational Foundation on Tuesday launched the Up and Away and Out of Sight educational program to help educate parents on the importance of keeping their medicines in a safe place from children. In recent years, the number of accidental overdoses in children increased by 20%, the agency and association stated.

December 14, 2011

A Food and Drug Administration panel has voted to recommend approval for a psychiatric drug made by Alexza Pharmaceuticals.

MOUNTAIN VIEW, Calif. — A Food and Drug Administration panel has voted to recommend approval for a psychiatric drug made by Alexza Pharmaceuticals.

December 14, 2011

The National Association of Chain Drug Stores on Wednesday challenged some of Express Scripts' and Medco's testimony during last week's hearing before the Senate Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights, most notably that PBMs are subject to state regulation in all states and that as a PBM the two companies have no influence on the design of prescription drug benefits.

ALEXANDRIA, Va. — The National Association of Chain Drug Stores on Wednesday challenged some of Express Scripts' and Medco's testimony during last week's hearing before the Senate Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights, most notably that PBMs are subject to state regulation in all states and that as a PBM the two companies have no influence on the design of prescription drug benefits.

December 14, 2011

North Carolina may be two years away from joining Oregon and Mississippi as the only states to classify pseudoepehdrine as a prescription-only medicine.

RALEIGH, N.C. — North Carolina may be two years away from joining Oregon and Mississippi as the only states to classify pseudoepehdrine as a prescription-only medicine.

December 13, 2011

The Federal Trade Commission has voted to approve Valeant's acquisitions of Dermik, a unit of French drug maker Sanofi that makes drugs for skin conditions, and Ortho Dermatologics, a division of Johnson & Johnson that also makes skin drugs.

MISSISSAUGA, Ontario — The Federal Trade Commission has voted to approve Valeant's acquisitions of Dermik, a unit of French drug maker Sanofi that makes drugs for skin conditions, and Ortho Dermatologics, a division of Johnson & Johnson that also makes skin drugs.

December 13, 2011

The Department of Health and Human Services on Monday announced that the first U.S. facility to use a faster and more flexible technology to make influenza vaccine was dedicated as part of an initiative that could provide vaccine supplies sooner in an influenza pandemic.

WASHINGTON — The Department of Health and Human Services on Monday announced that the first U.S. facility to use a faster and more flexible technology to make influenza vaccine was dedicated as part of an initiative that could provide vaccine supplies sooner in an influenza pandemic.

December 13, 2011

A new law in Washington state intended to curb accidental deaths related to opioid painkillers is having some adverse side effects, according to published reports.

NEW YORK — A new law in Washington state intended to curb accidental deaths related to opioid painkillers is having some adverse side effects, according to published reports.

December 13, 2011

New York state Gov. Andrew Cuomo has signed into law a bill that would forbid health insurers from requiring plan members to order prescription drugs from mail-order pharmacies, according to published reports.

NEW YORK — New York state Gov. Andrew Cuomo has signed into law a bill that would forbid health insurers from requiring plan members to order prescription drugs from mail-order pharmacies, according to published reports. 

December 12, 2011

The Food and Drug Administration has approved a new formulation of a painkiller made by Endo Pharmaceuticals designed to thwart drug abuse, Endo said Monday.

CHADDS FORD, Pa. — The Food and Drug Administration has approved a new formulation of a painkiller made by Endo Pharmaceuticals designed to thwart drug abuse, Endo said Monday.

Endo announced the FDA's approval of a crush-resistant version of Opana ER (oxymorphone). Drug abusers often crush opioid pills in order to smoke, inhale or inject them. Endo developed the new formulation of the drug, scheduled for launch in 2012, using Grunenthal's Intac technology. The new version will otherwise be identical to the old one.

December 12, 2011

The Food and Drug Administration has approved a generic painkiller made by Sun Pharmaceutical Industries, Sun said.

MUMBAI, India — The Food and Drug Administration has approved a generic painkiller made by Sun Pharmaceutical Industries, Sun said.

Sun announced the approval of tramadol hydrochloride extended-release tablets, a generic version of Valeant International's Ultram ER. The drug is used to treat moderate to moderately severe chronic pain in adults who need constant treatment for an extended period of time.

Various versions of the drug have annual sales of $125 million, according to Sun.

December 12, 2011

Following months of meetings and negotiations with the drug and chemical industries, the Food and Drug Administration has released a draft of the goals of the Generic Drug User Fee Act.

WASHINGTON — Following months of meetings and negotiations with the drug and chemical industries, the Food and Drug Administration has released a draft of the goals of the Generic Drug User Fee Act.

December 9, 2011

The Centers for Disease Control and Prevention on Thursday released new recommendations to treat latent tuberculosis infection.

ATLANTA — The Centers for Disease Control and Prevention on Thursday released new recommendations to treat latent tuberculosis infection.

The new recommendations, published in CDC’s Morbidity and Mortality Weekly Report, provide guidance on how to administer a new 12-dose regimen for TB preventive therapy that will significantly shorten and simplify the course of treatment from about nine months to 12 weeks. The recommendations are based on the results of three clinical trials, as well as expert opinion.

December 9, 2011

The Food and Drug Administration has approved a topical gel made by Antares Pharma for overactive bladder.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a topical gel made by Antares Pharma for overactive bladder.

Watson Pharmaceuticals announced Thursday the approval of oxybutynin gel in the 3% strength, which it will launch next year under a licensing agreement with Antares.

December 9, 2011

Preserve Community Pharmacy Access Now — a coalition of consumers, businesses and community-based pharmacists banded together for the purpose of opposing the planned merger between Express Scripts and Medco Health Solutions — on Thursday responded to testimony provided by George Paz, Express Scripts CEO, before the Senate Committee on the Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights hearing held Tuesday.

WASHINGTON — Preserve Community Pharmacy Access Now — a coalition of consumers, businesses and community-based pharmacists banded together for the purpose of opposing the planned merger between Express Scripts and Medco Health Solutions — on Thursday responded to testimony provided by George Paz, Express Scripts CEO, before the Senate Committee on the Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights hearing held Tuesday.

December 8, 2011

A Food and Drug Administration panel of 13 advisers has voted in favor of a drug made by Pfizer for treating kidney cancer, the drug maker said Wednesday.

NEW YORK — A Food and Drug Administration panel of 13 advisers has voted in favor of a drug made by Pfizer for treating kidney cancer, the drug maker said Wednesday.

Pfizer announced that the FDA's Oncologic Drugs Advisory Committee voted unanimously to state that axitinib's benefits outweighed its risks in patients with advanced renal cell carcinoma for whom first-line treatments had failed.

December 8, 2011

The Generic Pharmaceutical Association has appointed a new executive who will help guide the organization's newly created research and education institute.

WASHINGTON — The Generic Pharmaceutical Association has appointed a new executive who will help guide the organization's newly created research and education institute.

The organization announced Thursday the appointment of Ahaviah Glaser as VP policy and strategic alliances. Glaser previously was a member of AARP's government affairs team.

December 8, 2011

A group of medical associations on Wednesday denounced the government's decision to maintain the status quo with regard to the prescription status of the emergency contraceptive Plan B.

WASHINGTON — A group of medical associations on Wednesday denounced the government's decision to maintain the status quo with regard to the prescription status of the emergency contraceptive Plan B.

December 8, 2011

New legislation proposed in the Senate would strengthen penalties against people who traffic in counterfeit medications.

ALEXANDRIA, Va. — New legislation proposed in the Senate would strengthen penalties against people who traffic in counterfeit medications.

Introduced by Sen. Patrick Leahy, D-Vt., S. 1886, the Counterfeit Drug Penalty Enhancement Act of 2011, would harshen laws against producing, buying or selling counterfeit drugs. The bill has received support from the chain retail pharmacy lobby.

December 7, 2011

Five trade associations representing the dietary supplement industry on Tuesday collectively called for an overhaul of the Food and Drug Administration's draft guidance regarding new dietary ingredient reporting requirements.

WASHINGTON — Five trade associations representing the dietary supplement industry on Tuesday collectively called for an overhaul of the Food and Drug Administration's draft guidance regarding new dietary ingredient reporting requirements.

December 7, 2011

A drug in late-stage clinical trials appears to treat the symptoms of autism, the drug's developer said Wednesday.

RYE, N.Y. — A drug in late-stage clinical trials appears to treat the symptoms of autism, the drug's developer said Wednesday.

Curemark announced results of the phase-3 trial of CM-AT in children ages 3 to 8 years. The company said the drug had a statistically significant effect on symptoms of autism compared with placebo. The Food and Drug Administration has granted the drug fast-track status, which it does for investigational drugs to treat serious or life-threatening conditions that may address unmet medical needs.

December 7, 2011

Prescribers, patients and specialty care centers no longer will be required to enroll in safety monitoring programs for two drugs used to treat low platelet counts, following changes to their risk evaluation and mitigation strategies.

SILVER SPRING, Md. — Prescribers, patients and specialty care centers no longer will be required to enroll in safety monitoring programs for two drugs used to treat low platelet counts, following changes to their risk evaluation and mitigation strategies.

December 7, 2011

At the request of the Food and Drug Administration, U.S. marshals on Tuesday seized raw materials imported by Infinity Marketing Group containing ephedrine alkaloids, a large family of pharmacological compounds called sympathomimetics that have been banned by the FDA for use in dietary supplements since 2004.

SILVER SPRING, Md. — At the request of the Food and Drug Administration, U.S. marshals on Tuesday seized raw materials imported by Infinity Marketing Group containing ephedrine alkaloids, a large family of pharmacological compounds called sympathomimetics that have been banned by the FDA for use in dietary supplements since 2004.

The seizure took place in Rancho Dominguez, Calif. Through this action, FDA removed more than $70,000 worth of dietary supplement ingredients from the market.