Content about Regulatory and Washington

March 13, 2012

One-third or more of rogue online pharmacy domains are under one Internet registrar, with two registrars accounting for more than half, according to a new report.

NEW YORK — One-third or more of rogue online pharmacy domains are under one Internet registrar, with two registrars accounting for more than half, according to a new report.

March 13, 2012

The National Association of Chain Drug Stores is heading to Capitol Hill next week for its RxImpact Day event, during which it will press its case against the proposed ESI-Medco merger.

WASHINGTON — The National Association of Chain Drug Stores is heading to Capitol Hill next week for its RxImpact Day event, during which it will press its case against the proposed ESI-Medco merger.

“No issues are higher on NACDS’ list of priorities than urging members of Congress to express to the Federal Trade Commission their concerns and opposition to the proposed Express Scripts and Medco merger, and advocating for legislation to regulate pharmacy benefit managers,” stated NACDS president and CEO Steve Anderson.

March 13, 2012

West Virginia has become the 19th state to require pharmacists and other retailers to be connected through the National Precursor Log Exchange system with the passage of legislation that requires real-time, stop-sale technology to enable the state's pharmacists to block illegal pseudoephedrine purchases right at the point of sale and provide law enforcement with up-to-the minute criminal data.

WASHINGTON — West Virginia has become the 19th state to require pharmacists and other retailers to be connected through the National Precursor Log Exchange system with the passage of legislation that requires real-time, stop-sale technology to enable the state's pharmacists to block illegal pseudoephedrine purchases right at the point of sale and provide law enforcement with up-to-the minute criminal data.

March 12, 2012

One of pharmacy's top awards is getting some support from a German drug maker. Boehringer Ingelheim announced that it became a premier supporter of the American Pharmacists Association's Bowl of Hygeia Award.

RIDGEFIELD, Conn. — One of pharmacy's top awards is getting some support from a German drug maker. Boehringer Ingelheim announced that it became a premier supporter of the American Pharmacists Association's Bowl of Hygeia Award.

March 9, 2012

A new partnership aims to educate pharmacists, other healthcare professionals, caregivers and patients about diabetes and about how pharmacists can work with physicians to help patients manage the condition.

WASHINGTON — A new partnership aims to educate pharmacists, other healthcare professionals, caregivers and patients about diabetes and about how pharmacists can work with physicians to help patients manage the condition.

The American Pharmacists Association, the APhA Foundation and the American Diabetes Association announced the collaboration Friday, saying it would develop new resources and also promote existing programs, such as the ADA's Stop Diabetes Movement and the APhA's Pharmaceutical Care for Patients with Diabetes certification program.

March 9, 2012

The Food and Drug Administration has approved a version of a drug made by Teva that includes a dose counter, the drug maker said.

NORTH WALES, Pa. — The Food and Drug Administration has approved a version of a drug made by Teva that includes a dose counter, the drug maker said.

Teva announced the approval of the inhaled drug ProAir HFA (albuterol sulfate) with a dose counter for treating bronchospasm with reversible obstructive airway disease and preventing exercise-induced bronchospasm in patients ages 4 years and older. The dose counter is designed to help patients and caregivers keep track of the number of doses in the canister.

March 9, 2012

A Food and Drug Administration panel will meet Monday to discuss a class of drugs designed to treat chronic painful conditions that currently are under development and the safety issues possibly related to the drugs.

WASHINGTON — A Food and Drug Administration panel will meet Monday to discuss a class of drugs designed to treat chronic painful conditions that currently are under development and the safety issues possibly related to the drugs.

March 9, 2012

The National Association of Chain Drug Stores on Friday applauded the Senate for passage of the Counterfeit Drug Penalty Enhancement Act (S. 1886), which NACDS said would protect the health and safety of consumers by increasing penalties on criminals that engage in the harmful practice of trafficking in counterfeit medications.

ALEXANDRIA, Va. — The National Association of Chain Drug Stores on Friday applauded the Senate for passage of the Counterfeit Drug Penalty Enhancement Act (S. 1886), which NACDS said would protect the health and safety of consumers by increasing penalties on criminals that engage in the harmful practice of trafficking in counterfeit medications.

The bill is sponsored by Sens. Patrick Leahy, D-Vt., Charles Grassley, R-Iowa, and Michael Bennet, D-Colo.



March 9, 2012

The U.S. surgeon general this week released a report on tobacco use among the nation's youth.

WASHINGTON — The U.S. surgeon general this week released a report on tobacco use among the nation's youth.

March 8, 2012

A Consumer Healthcare Products Association study earlier this year supported what everyone has known all along: Use of over-the-counter medicines saves the U.S. healthcare system money. A lot of it. 


WASHINgTON — A Consumer Healthcare Products Association study earlier this year supported what everyone has known all along: Use of over-the-counter medicines saves the U.S. healthcare system money. A lot of it. 


For every dollar spent on over-the-counter medicines, the U.S. healthcare system realizes a savings of between $6 and $7, or $102 billion all told, according to CHPA’s study, “The Value of OTC Medicine to the United States.”


March 8, 2012

A blood-glucose monitoring system created by Abbott has received clearance from the Food and Drug Administration.

ALAMEDA, Calif. — A blood-glucose monitoring system created by Abbott has received clearance from the Food and Drug Administration.

March 8, 2012

The Food and Drug Administration is looking at the possibility of selling certain prescription drugs over the counter under specific circumstances, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration is looking at the possibility of selling certain prescription drugs over the counter under specific circumstances, the agency said.

March 8, 2012

The number of patients with diabetes is not decreasing any time soon, and one of the most important fronts in the battle lies at the pharmacy counter.


The number of patients with diabetes is not decreasing any time soon, and one of the most important fronts in the battle lies at the pharmacy counter.


March 8, 2012

Written testimony submitted by the National Association of Chain Drug Stores underscored chain pharmacies’ commitment to patient safety as part of the next Prescription Drug User Fee Act reauthorization, and emphasized that community pharmacist-provided services help improve health outcomes without the introduction of unproven technologies.

ALEXANDRIA, Va. — Written testimony submitted by the National Association of Chain Drug Stores underscored chain pharmacies’ commitment to patient safety as part of the next Prescription Drug User Fee Act reauthorization, and emphasized that community pharmacist-provided services help improve health outcomes without the introduction of unproven technologies.

March 7, 2012

Prices for generic drugs may be dropping, but increases in branded and specialty drug prices have offset those decreases, according to a new study.

WASHINGTON — Prices for generic drugs may be dropping, but increases in branded and specialty drug prices have offset those decreases, according to a new study.

The study, conducted by AARP's Public Policy Institute, found that the cumulative change in drug prices from 2005 to 2009 was almost double the rate of inflation. As a result, the average annual cost of drug therapy continued to rise.

March 7, 2012

The maker of a breathable caffeine product has received a warning letter from the Food and Drug Administration.

WASHINGTON — The maker of a breathable caffeine product has received a warning letter from the Food and Drug Administration.

March 7, 2012

The Food and Drug Administration has declined to approve a drug made by Eisai for leukemia in certain elderly patients, the drug maker said.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has declined to approve a drug made by Eisai for leukemia in certain elderly patients, the drug maker said.

Eisai said the FDA delivered it a complete response letter for the chemotherapy drug Dacogen (decitabine) in patients ages 65 years and older with acute myeloid leukemia who are not candidates for induction therapy. The FDA delivers a complete response letter when questions remain about an regulatory application that preclude approval, usually due to insufficient clinical trial data.

March 7, 2012

The Consumer Healthcare Products Association on Tuesday named John Gay as the association's VP government affairs.

WASHINGTON — The Consumer Healthcare Products Association on Tuesday named John Gay as the association's VP government affairs. Gay will begin his duties March 8.

Reporting to CHPA president and CEO Scott Melville, Gay will oversee the association’s state and federal government affairs departments, its political action committee, and will serve as a member of the association’s senior management team.

March 7, 2012

Two lawmakers are calling for a congressional hearing surrounding the role of pharmacy benefit managers in the Medicare Part D prescription drug program.

ALEXANDRIA, Va. — Two lawmakers are calling for a congressional hearing surrounding the role of pharmacy benefit managers in the Medicare Part D prescription drug program.

March 7, 2012

The Retail Industry Leaders Association, in partnership with Auburn University and with sponsorship from Accenture, on Wednesday released the third annual State of The Retail Supply Chain report.

ARLINGTON, Va. — The Retail Industry Leaders Association, in partnership with Auburn University and with sponsorship from Accenture, on Wednesday released the third annual State of The Retail Supply Chain report.

@RILAtweets will moderate a live Twitter chat March 7 from 12 noon to 1 p.m. EST via #RILAchat to discuss the report findings.

March 6, 2012

The Food and Drug Administration has approved a new formulation of a drug for postmenopausal women.

WAYNE, N.J. — The Food and Drug Administration has approved a new formulation of a drug for postmenopausal women.

Bayer HealthCare Pharmaceuticals said the FDA approved a lower-dose formulation of Angeliq (drospirenone and estradiol) tablets, used to treat moderate to severe vasomotor symptoms due to menopause in women who have a uterus. The new formulation contains 0.25-mg drospirenone and 0.5-mg estradiol, while the previously approved formulation contained 0.5-mg drospirenone and 1-mg estradiol.

March 6, 2012

The Food and Drug Administration is asking for additional data before it approves a new cholesterol drug made by Merck, the drug maker said.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration is asking for additional data before it approves a new cholesterol drug made by Merck, the drug maker said.

Merck said the agency issued a complete response letter for its regulatory approval application for a drug that would combine the cholesterol drug Zetia (ezetimibe) with atorvastatin, the active ingredient in Pfizer's Lipitor. A complete response letter means that the FDA cannot approve a drug application in its current form.

March 5, 2012

The National Community Pharmacists Association has renewed two of its pharmacy niche programs.

ALEXANDRIA, Va. — The National Community Pharmacists Association has renewed two of its pharmacy niche programs.

March 5, 2012

Cardinal Health can continue distributing controlled medications from a distribution center in Florida, according to published reports.

NEW YORK — Cardinal Health can continue distributing controlled medications from a distribution center in Florida, according to published reports.

On Friday, the U.S. Court of Appeals for the District of Columbia Circuit put a stay on the Drug Enforcement Administration's order that had blocked Cardinal from shipping controlled substances from the Lakeland, Fla., center. The stay will last until the middle of the month, when Cardinal has to file its emergency motion, and the DEA has to file its response, according to the reports.

March 5, 2012

Walgreens last week outlined how the company's research has demonstrated the ability of face-to-face pharmacy and Take Care Clinic programs to drive better health outcomes at the IMS Managed Markets Services/Data Niche Conference held here.

LAS VEGAS — Walgreens last week outlined how the company's research has demonstrated the ability of face-to-face pharmacy and Take Care Clinic programs to drive better health outcomes at the IMS Managed Markets Services/Data Niche Conference held here.

Some of the savings advantages inherent in the offerings provided by Walgreens include: