Content about commissioner

November 14, 2012

Food and Drug Administration commissioner Margaret Hamburg is asking Congress to give the agency more power to regulate compounding pharmacies amid a national meningitis outbreak linked to a Massachusetts-based compounding pharmacy that has claimed dozens of lives nationwide.

NEW YORK — Food and Drug Administration commissioner Margaret Hamburg is asking Congress to give the agency more power to regulate compounding pharmacies amid a nationwide meningitis outbreak linked to a Massachusetts-based compounding pharmacy that has claimed dozens of lives nationwide.

October 25, 2012

New York City Mayor Michael Bloomberg and Health Commissioner Thomas Farley received their seasonal flu vaccination Thursday morning at a Duane Reade pharmacy in New York City, demonstrating the importance of taking proactive steps to prevent the spread of influenza.

NEW YORK CITY — New York City Mayor Michael Bloomberg and Health Commissioner Thomas Farley received their seasonal flu vaccination Thursday morning at a Duane Reade pharmacy in New York City, demonstrating the importance of taking proactive steps to prevent the spread of influenza.

October 15, 2012

The Food and Drug Administration may be willing to speed up trials for drugs that could be a big benefit to society despite their risks.

SILVER SPRING, M.D. — The Food and Drug Administration may be willing to speed up trials for drugs that could be a big benefit to society despite their risks.

According to several published reports, FDA commissioner Margaret Hamburg recently told a group of scientific advisers that the agency is considering allowing makers of drugs having a societal benefit to conduct faster clinical trials with a smaller group of patients than is now required.

October 9, 2012

The New York City health commissioner’s ban on the sale of big cups of fountain soda drew many an unfavorable accusation that the administration of mayor Michael Bloomberg was trying to turn the city into a nanny state, with NaturalNews.com editor Mike Adams asking, “What’s next? Is Bloomberg gonna pull a Singapore and ban chewing gum too?”


The New York City health commissioner’s ban on the sale of big cups of fountain soda drew many an unfavorable accusation that the administration of mayor Michael Bloomberg was trying to turn the city into a nanny state, with NaturalNews.com editor Mike Adams asking, “What’s next? Is Bloomberg gonna pull a Singapore and ban chewing gum too?”


October 5, 2012

In partnership with international regulatory and law enforcement agencies, the Food and Drug Administration on Thursday announced it had taken action against more than 4,100 Internet pharmacies that illegally sell unapproved drugs to consumers.

SILVER SPRING, Md. — In partnership with international regulatory and law enforcement agencies, the Food and Drug Administration on Thursday announced it had taken action against more than 4,100 Internet pharmacies that illegally sell unapproved drugs to consumers. Actions taken include civil and criminal charges, seizure of illegal products and removal of offending websites.

September 28, 2012

Keynote speeches by pharmaceutical industry and regulatory leaders got top billing as more than 140 government, healthcare industry, law enforcement and patient advocacy officials gathered to find ways to combat the spread of counterfeit medicines.

WASHINGTON — Keynote speeches by pharmaceutical industry and regulatory leaders got top billing as more than 140 government, healthcare industry, law enforcement and patient advocacy officials gathered to find ways to combat the spread of counterfeit medicines.

August 10, 2012

Walgreens on Saturday will be hosting its first Mobile Photo Hack Day — a contest among mobile photo application developers in creating a "groundbreaking" application using Walgreens' QuickPrints SDK.

CHICAGO — Walgreens on Saturday will be hosting its first Mobile Photo Hack Day — a contest among mobile photo application developers in creating a "groundbreaking" application using Walgreens' QuickPrints SDK.

All entries will be reviewed by a panel of notable judges:

  • Kobie Hatcher, solutions director at AIM Consulting, a technology solutions and services company providing resources in flexible configurations;

May 16, 2012

A consumer group is urging the Food and Drug Administration to review a proprietary point-of-purchase nutrition rating system that it said is "inconsistent with FDA guidance statements and enforcement correspondence, federal nutrition programs and recommendations from the Institute of Medicine."

WASHINGTON — A consumer group is urging the Food and Drug Administration to review a proprietary point-of-purchase nutrition rating system that it said is "inconsistent with FDA guidance statements and enforcement correspondence, federal nutrition programs and recommendations from the Institute of Medicine."

May 11, 2012

There is an important distinction to be made here, one that could place pharmacy operators and over-the-counter manufacturers on opposite sides of the aisle.

WHAT IT MEANS AND WHY IT'S IMPORTANT — There is an important distinction to be made here, one that could place pharmacy operators and over-the-counter manufacturers on opposite sides of the aisle. And that's the call for a codified third class of drugs, made more or less by both the National Association of Chain Drug Stores and the National Community Pharmacists Association in their written submissions to the Food and Drug Administration on expanding the switch paradigm.

May 4, 2012

The number of new drug shortages has been halved as early notifications from manufacturers of potential shortages have increased sixfold, the commissioner of the Food and Drug Administration wrote Thursday.

SILVER SPRING, Md. — The number of new drug shortages has been halved as early notifications from manufacturers of potential shortages have increased sixfold, the commissioner of the Food and Drug Administration wrote Thursday.

April 2, 2012

“Straight over the cliff.” That may be the destination for many independent pharmacies now that the Federal Trade Commission has unconditionally approved the controversial merger of the nation’s second- and third-largest pharmacy benefit managers, a top pharmacy leader warned.

“Straight over the cliff.”

That may be the destination for many independent pharmacies now that the Federal Trade Commission unconditionally has approved the controversial merger of the nation’s second- and third-largest pharmacy benefit managers, a top pharmacy leader warned.

April 2, 2012

The controversial merger between Express Scripts and Medco was completed Monday morning, according to a press release issued by both Express Scripts and the Federal Trade Commission.

WASHINGTON — The controversial merger between Express Scripts and Medco was completed Monday morning, according to a press release issued by both Express Scripts and the Federal Trade Commission.

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 7, 2011

Food and Drug Administration commissioner Margaret Hamburg on Wednesday issued a public statement that the agency was prepared to approve Plan B as a nonprescription medication, but reversed that decision following a directive from the Department of Health and Human Services Wednesday morning.

SILVER SPRING, Md. — Food and Drug Administration commissioner Margaret Hamburg on Wednesday issued a public statement that the agency was prepared to approve Plan B as a nonprescription medication, but reversed that decision following a directive from the Department of Health and Human Services Wednesday morning.

November 15, 2011

The generic drug lobby is stepping up its efforts to persuade the congressional super committee to avoid adopting rules that would ban some patent settlements between branded and generic drug makers.

WASHINGTON — The generic drug lobby is stepping up its efforts to persuade the congressional super committee to avoid adopting rules that would ban some patent settlements between branded and generic drug makers.

November 7, 2011

The Food and Drug Administration has appointed a new chief of staff for commissioner Margaret Hamburg, according to a letter sent to agency employees Monday.

SILVER SPRING, Md. — The Food and Drug Administration has appointed a new chief of staff for commissioner Margaret Hamburg, according to a letter sent to agency employees Monday.

In the letter, Hamburg announced the appointment of Lisa Barclay. Barclay, currently a partner at the Washington law firm Zuckerman Spaeder, will replace Molly Muldoon, who was previously chief of staff and more recently the agency's acting COO.

November 3, 2011

The Food and Drug Administration has approved 35 new drugs over the past 12 months, the agency said Thursday.

SILVER SPRING, Md. — The Food and Drug Administration has approved 35 new drugs over the past 12 months, the agency said Thursday.

October 31, 2011

New York City mayor Michael Bloomberg and health commissioner Thomas Farley received their seasonal flu vaccine on Saturday at a Duane Reade pharmacy in the Bronx, demonstrating the importance of taking steps to prevent the spread of the virus.

NEW YORK — New York City mayor Michael Bloomberg and health commissioner Thomas Farley received their seasonal flu vaccine on Saturday at a Duane Reade pharmacy in the Bronx, demonstrating the importance of taking steps to prevent the spread of the virus.

“Every year, New Yorkers lose their lives to the flu, and a flu shot is the single most important protection against getting sick and spreading the flu to others,” Bloomberg said. “I urge everyone to go to their doctor, local health clinic or pharmacy and get a flu shot as soon as they can.”

August 24, 2011


A worldwide flood of counterfeit and unsafe medications is seeping into the United States and other developed countries via the Internet and porous borders, threatening public health and the security of the pharmaceutical supply chain.


A worldwide flood of counterfeit and unsafe medications is seeping into the United States and other developed countries via the Internet and porous borders, threatening public health and the security of the pharmaceutical supply chain. In response, federal drug safety overseers and such drug manufacturers as Pfizer are working to shore up the integrity of drug supplies and stop production of fake and adulterated pharmaceuticals at their source.


March 15, 2011

Five senators have issued a letter to Food and Drug Administration commissioner Margaret Hamburg to expand Americans' access to affordable medications by avoiding the delay of generic drug approvals.

WASHINGTON — Five senators have issued a letter to Food and Drug Administration commissioner Margaret Hamburg to expand Americans' access to affordable medications by avoiding the delay of generic drug approvals.

January 5, 2011

Food and Drug Administration principal deputy commissioner Joshua Sharfstein will leave the agency to become head of the Maryland Department of Health and Mental Hygiene, according to published reports.

SILVER SPRING, Md. — Food and Drug Administration principal deputy commissioner Joshua Sharfstein will leave the agency to become head of the Maryland Department of Health and Mental Hygiene, according to published reports.

The Washington Post reported Wednesday that Sharfstein, the FDA’s top official after commissioner Margaret Hamburg, had received an invitation to head the state health department from Gov. Martin O’Malley.

Before assuming his position at the FDA, Sharfstein served as head of the Baltimore City Health Department.

December 7, 2010

ALEXANDRIA, Va. — Simplify, simplify.


November 14, 2010

A backlog of more than 2,000 drug entities and devices is awaiting approval. That’s the...

ROCKVILLE, Md. — A backlog of more than 2,000 drug entities and devices is awaiting approval. That’s the situation facing the Food and Drug Administration and the generic pharmaceutical industry—and it’s the chief impetus behind the FDA’s push to impose user fees on generic drug makers seeking the agency’s review and approval for their brand-equivalent medicines.

November 9, 2010

To express it in modern parlance, follow-on biologics will be a hot mess....

NEW YORK To express it in modern parlance, follow-on biologics will be a hot mess.

 

While speaking at the Reuters Health Summit, according to Reuters, Food and Drug Administration commissioner Margaret Hamburg didn’t put it quite that colorfully, but she had said the science will evolve, meaning a regulatory approval pathway never will be a truly done deal.

 

 

November 1, 2010

The National Association of Chain Drug Stores is urging federal health officials to adopt a...

ALEXANDRIA, Va. The National Association of Chain Drug Stores is urging federal health officials to adopt a simpler means of communicating drug safety and efficacy information to patients, and to clear the way for an approval pathway for generic versions of biologically engineered drugs.

 

NACDS made its priorities known in a letter Monday to Margaret Hamburg, commissioner of the Food and Drug Administration. The letter came from Kevin Nicholson, the group’s VP government affairs and public policy.