Content about Regulatory and Washington

March 12, 2014

Citing pharmacist-administered medication therapy management, recognition of pharmacists as healthcare providers, the need for fair and accurate pharmacy reimbursement in state Medicaid programs and other pharmacy services, the National Association of Chain Drug Stores has sent a statement to lawmakers urging them to consider pharmacy provisions within the “Fiscal 2015 Budget,” released by the administration last week.

ARLINGTON, Va. – Citing pharmacist-administered medication therapy management, recognition of pharmacists as healthcare providers, the need for fair and accurate pharmacy reimbursement in state Medicaid programs and other pharmacy services, the National Association of Chain Drug Stores has sent a statement to lawmakers urging them to consider pharmacy provisions within the “Fiscal 2015 Budget,” released by the administration last week.

March 12, 2014

Walmart has joined almost two-dozen organizations from across the healthcare supply chain in a letter calling on the Food and Drug Administration to consider the public health impact of its Proposed Rule on pharmaceutical labeling.

WASHINGTON, D.C. — Walmart has joined almost two-dozen organizations from across the healthcare supply chain in a letter calling on the Food and Drug Administration to consider the public health impact of its Proposed Rule on pharmaceutical labeling.

March 11, 2014

The Centers for Medicare and Medicaid Services has decided not to move forward on several of the proposed provisions of the Medicare Advantage and Part D prescription drug program, according to reports.

WASHINGTON — The Centers for Medicare and Medicaid Services has decided not to move forward on several of the proposed provisions of the Medicare Advantage and Part D prescription drug program, according to reports.

March 11, 2014

Bipartisan legislation that would designate pharmacists as healthcare providers under the Medicare program was introduced in the U.S. House of Representatives on Tuesday. The bill would amend The Social Security Act of 1935 to enable pharmacists to work to their full capability by providing underserved patients in the Medicare program with services not currently available to them.

ARLINGTON, Va. — Bipartisan legislation that would designate pharmacists as healthcare providers under the Medicare program was introduced in the U.S. House of Representatives on Tuesday. The bill would amend The Social Security Act of 1935 to enable pharmacists to work to their full capability by providing underserved patients in the Medicare program with services not currently available to them.

March 10, 2014

The majority of pediatric bacterial infections that cause severe diarrhea and are potentially life-threatening occur among children who recently took antibiotics prescribed by doctors for other conditions, according to a new study by the Centers for Disease Control and Prevention published this week in Pediatrics.

NEW YORK — The majority of pediatric bacterial infections that cause severe diarrhea and are potentially life-threatening occur among children who recently took antibiotics prescribed by doctors for other conditions, according to a new study by the Centers for Disease Control and Prevention published this week in Pediatrics.

March 10, 2014

Although the United States is still waiting for final practical guidelines from the Food and Drug Administration about the launch of biosimilars and the standards required to meet the threshold of interchangeability, the rest of the world seems to be barreling forward with the development and launch of these important medicines.

Although the United States is still waiting for final practical guidelines from the Food and Drug Administration about the launch of biosimilars and the standards required to meet the threshold of interchangeability, the rest of the world seems to be barreling forward with the development and launch of these important medicines. By the end of this decade, a significant number of blockbuster drugs will go off patent, paving the way for biosimlar market entrance.

March 10, 2014

Two Rx-to-OTC switches in the past year may serve as a harbinger of what the Food and Drug Administration will consider “switch” worthy.

Two Rx-to-OTC switches in the past year may serve as a harbinger of what the Food and Drug Administration will consider “switch” worthy. They both address chronic care needs, and they both represent first of their kind medicines to the nonprescription aisle.

March 10, 2014

A Maryland bill that is intended to help pharmacies in managing inventories and avoid potential drug shortages could create hardships for distributors, according to an FDA law blog.

WASHINGTON — A Maryland bill that is intended to help pharmacies in managing inventories and avoid potential drug shortages could create hardships for distributors, according to an FDA law blog.

March 7, 2014

A study published online Friday shows that the omega-3 fatty acids EPA and DHA — commonly found in fatty fish and fish oil supplements — are as effective, if not more effective, in lowering blood pressure as some of the commonly recommended lifestyle changes like increasing physical activity and restricting alcohol and sodium intake.

SALT LAKE CITY — A study published online Friday shows that the omega-3 fatty acids EPA and DHA — commonly found in fatty fish and fish oil supplements — are as effective, if not more effective, in lowering blood pressure as some of the commonly recommended lifestyle changes like increasing physical activity and restricting alcohol and sodium intake. The findings, released by the American Journal of Hypertension, are good news, especially for those with elevated blood pressure.

March 6, 2014

In anticipation of the March 13 deadline for comments on the FDA's proposed rule on prescription generic drug labeling, 21 health industry groups submitted a new letter to the agency on Thursday, raising concerns about the proposed regulation.

WASHINGTON — In anticipation of the March 13 deadline for comments on the FDA's proposed rule on prescription generic drug labeling, 21 health industry groups submitted a new letter to the agency on Thursday, raising concerns about the proposed regulation. 

March 6, 2014

Could retail-based health clinics be coming soon to Boston? While it appears that there are no definite plans in the works, a spokeswoman for Mayor Martin J. Walsh reportedly said that he has no intention of blocking the clinics from coming to Boston, the Boston Herald reported.

BOSTON — Could retail-based health clinics be coming soon to Boston?

While it appears that there are no definite plans in the works, a spokeswoman for Mayor Martin J. Walsh reportedly said that he has no intention of blocking the clinics from coming to Boston, the Boston Herald reported.

March 6, 2014

The administration is seeking $4.7 billion for the Food and Drug Administration, representing a 6.8% increase, according to a report published Tuesday by the Washington Post.

WASHINGTON — The administration is seeking $4.7 billion for the Food and Drug Administration, representing a 6.8% increase, according to a report published Tuesday by the Washington Post

According to the report, the budget includes $25 million to register and inspect large-scale compounding pharmacies.

March 5, 2014

Most people who abuse prescription opioid drugs get them for free from a friend or relative — but those at highest risk of overdose are as likely to get them from a doctor’s prescription, Centers for Disease Control researchers reported Monday in a research letter, “Sources of Prescription Opioid Pain Relievers by Frequency of Past-Year Nonmedical Use: United States, 2008-2011,” in the Journal of the American Medical Association Internal Medicine.

ATLANTA — Most people who abuse prescription opioid drugs get them for free from a friend or relative — but those at highest risk of overdose are as likely to get them from a doctor’s prescription, Centers for Disease Control researchers reported Monday in a research letter, “Sources of Prescription Opioid Pain Relievers by Frequency of Past-Year Nonmedical Use: United States, 2008-2011,” in the Journal of the American Medical Association Internal Medicine.

March 5, 2014

In what could turn into a significant change of how retail pharmacy supplies hydrocodone combination products, the Drug Enforcement Administration last week published in the Federal Register a Notice of Proposed Rulemaking to move HCPs from Schedule III to Schedule II, as recommended by the assistant secretary for health of the Department of Health and Human Services and as supported by the DEA’s evaluation of relevant data.

WASHINGTON — In what could turn into a significant change of how retail pharmacy supplies hydrocodone combination products, the Drug Enforcement Administration last week published in the Federal Register a Notice of Proposed Rulemaking to move HCPs from Schedule III to Schedule II, as recommended by the assistant secretary for Health of the department of Health and Human Services and as supported by the DEA’s evaluation of relevant data.  

March 3, 2014

The Food and Drug Administration last week ruled that generic equivalents to Teva Pharmaceutical's Plan B emergency contraceptive can be sold alongside Plan B without any behind-the-counter merchandising restrictions or a requirement to verify the age of the purchaser in a letter to the interested parties.

SILVER SPRING, Md. — The Food and Drug Administration last week ruled that generic equivalents to Teva Pharmaceutical's Plan B emergency contraceptive can be sold alongside Plan B without any behind-the-counter merchandising restrictions or a requirement to verify the age of the purchaser in a letter to the interested parties

March 3, 2014

The Generic Pharmaceutical Association on Friday hosted a Congressional briefing highlighting the economic impact the Food and Drug Administration’s proposed rule on prescription labeling that would allow for label changes without prior FDA approval.

WASHINGTON — The Generic Pharmaceutical Association on Friday hosted a Congressional briefing highlighting the economic impact the Food and Drug Administration’s proposed rule on prescription labeling that would allow for label changes without prior FDA approval.

March 3, 2014

Last week, more than 30 organizations — including the American Medical Association, Infectious Diseases Society of America and Pew Charitable Trusts — urged Congressional leaders to strengthen the labeling requirements for drugs approved under the proposed Antibiotic Development to Advance Patient Treatment Act of 2013 (ADAPT Act) limited population approval pathway, which will streamline regulatory approval for antibiotics.

WASHINGTON — Last week, more than 30 organizations  — including the American Medical Association, Infectious Diseases Society of America and Pew Charitable Trusts — urged Congressional leaders to strengthen the labeling requirements for drugs approved under the proposed Antibiotic Development to Advance Patient Treatment Act of 2013 (ADAPT Act) limited population approval pathway, which will streamline regulatory approval for antibiotics. 

March 3, 2014

"The problem [of counterfeit medicines] is so big, disperse and complex that it requires a sweeping coordinated global response," wrote Scott LaGanga, executive director of the Partnership for Safe Medicines and SVP public affairs and advocacy for PhRMA in a blog published by The Hill on Saturday.

WASHINGTON — "The problem [of counterfeit medicines] is so big, disperse and complex that it requires a sweeping coordinated global response," wrote Scott LaGanga, executive director of the Partnership for Safe Medicines and SVP public affairs and advocacy for PhRMA in a blog published by The Hill on Saturday.

February 28, 2014

The Consumer Healthcare Products Association earlier this week voiced support for keeping over-the-counter bronchodilators in the OTC Monograph during a recent meeting of the Food and Drug Administration’s Nonprescription Drugs Advisory Committee.

WASHINGTON — The Consumer Healthcare Products Association earlier this week voiced support for keeping over-the-counter bronchodilators in the OTC Monograph during a recent meeting of the Food and Drug Administration’s Nonprescription Drugs Advisory Committee. 

February 28, 2014

The Council for Responsible Nutrition on Friday welcomed news of the U.S. Food and Drug Administration’s proposed rule, “Food Labeling: Revision of the Nutrition and Supplement Facts Labels.”

WASHINGTON — The Council for Responsible Nutrition on Friday welcomed news of the U.S. Food and Drug Administration’s proposed rule, “Food Labeling: Revision of the Nutrition and Supplement Facts Labels.”

February 27, 2014

The Food and Drug Administration on Thursday proposed to update the Nutrition Facts label for packaged foods to reflect the latest scientific information, including the link between diet and such chronic diseases as obesity and heart disease.

SILVER SPRING, Md. — The Food and Drug Administration on Thursday proposed to update the Nutrition Facts label for packaged foods to reflect the latest scientific information, including the link between diet and such chronic diseases as obesity and heart disease. The proposed label also would replace out-of-date serving sizes to better align with how much people really eat, and it would feature a fresh design to highlight key parts of the label such as calories and serving sizes.

February 27, 2014

As one of the most accessible healthcare providers in the community, pharmacists are an ideal resource for consumers on the risks of illegal Internet drug sellers. That was a key message that the National Association of Chain Drug Stores stressed in a statement submitted to a congressional panel.

ARLINGTON, Va. — As one of the most accessible healthcare providers in the community, pharmacists are an ideal resource for consumers on the risks of illegal Internet drug sellers. That was a key message that the National Association of Chain Drug Stores stressed in a statement submitted to a congressional panel.

The U.S. House of Representatives Energy and Commerce Subcommittee on Oversight and Investigations held a hearing titled “Counterfeit Drugs: Fighting Illegal Supply Chains.”

February 26, 2014

A pair of Food and Drug Administration advisory committees on Tuesday voted against the over-the-counter sale of Armstrong Pharmaceuticals' Primatene HFA, an epinephrine inhalation aerosol indicated for the temporary relief of mild symptoms of intermittent asthma for people ages 12 years or older.

SILVER SPRING, Md. — A pair of Food and Drug Administration advisory committees on Tuesday voted against the over-the-counter sale of Armstrong Pharmaceuticals' Primatene HFA, an epinephrine inhalation aerosol indicated for the temporary relief of mild symptoms of intermittent asthma for people ages 12 years or older.

February 25, 2014

The Drug Enforcement Administration's Atlanta Field Division last week announced the launch of an anonymous statewide prescription drug texting tip line available to the public.

ATLANTA — The Drug Enforcement Administration's Atlanta Field Division last week announced the launch of an anonymous statewide prescription drug texting tip line available to the public. 

February 25, 2014

Healtheway on Monday announced the formation of Carequality, a new initiative dedicated to accelerating progress in health data exchange among multiplatform networks, healthcare providers, electronic health record vendors and health information exchange vendors.

ORLANDO, Fla. — Healtheway on Monday announced the formation of Carequality, a new initiative dedicated to accelerating progress in health data exchange among multiplatform networks, healthcare providers, electronic health record vendors and health information exchange vendors. Carequality is an open, transparent and inclusive industry-driven effort. It will convene stakeholders and facilitate industry consensus to develop and maintain a standards-based interoperability framework that enables information exchange between and among networks.