Content about Ralph Neas

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 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. 

February 21, 2014

Food and Drug Administration Office of Generic Drugs' acting director Kathleen Uhl highlighted the industry and FDA’s shared commitment to Generic Drug User Fee Act milestones and approaching metrics in her keynote address at the GPhA Annual Meeting taking place here.

ORLANDO, Fla. — Food and Drug Administration Office of Generic Drugs' acting director Kathleen Uhl on Thursday highlighted the industry and FDA’s shared commitment to Generic Drug User Fee Act milestones and approaching metrics in her keynote address at the GPhA Annual Meeting taking place here.

February 20, 2014

The Generic Pharmaceutical Association on Wednesday announced that Craig Wheeler, president and CEO, Momenta Pharmaceuticals, was elected as GPhA board chairman.

ORLANDO, Fla. — The Generic Pharmaceutical Association on Wednesday announced that Craig Wheeler, president and CEO, Momenta Pharmaceuticals, was elected as GPhA board chairman. Wheeler succeeds Tony Mauro, president, Mylan North America. 

February 11, 2014

The Generic Pharmaceutical Association announced its support of Georgia SB 370, introduced by pharmacist and Sen. Buddy Carter, R-Ga. District 1, because it will allow unimpeded patient access to interchangeable biologics.

WASHINGTON — The Generic Pharmaceutical Association on Tuesday announced its support of Georgia SB 370, introduced by pharmacist and Sen. Buddy Carter, R-Ga. District 1,  because it will allow unimpeded patient access to interchangeable biologics. The bill mirrors current pharmacy practice for interchangeable generic substitution language, and is aligned with Food and Drug Administration definitions, the association noted.

February 6, 2014

The Food and Drug Administration’s proposed rule on prescription drug labeling would add $4 billion annually to the nation’s healthcare costs, undercutting the cost savings that generic medicines have brought to America’s patients and healthcare system, according to an analysis released Wednesday by economic consulting firm Matrix Global Advisors.

WASHINGTON — The Food and Drug Administration’s proposed rule on prescription drug labeling would add $4 billion annually to the nation’s healthcare costs, undercutting the cost savings that generic medicines have brought to America’s patients and healthcare system, according to an analysis released Wednesday by economic consulting firm Matrix Global Advisors.

February 3, 2014

The Generic Pharmaceutical Association on Monday identified its key priorities for 2014 — guarding against confusion a proposed labeling change would cause; gaining access to biosimilar generics; and heralding the cost savings generated by generic utilization.

WASHINGTON — The Generic Pharmaceutical Association on Monday identified its key priorities for 2014 — guarding against confusion a proposed labeling change would cause; gaining access to biosimilar generics; and heralding the cost savings generated by generic utilization. 

January 31, 2014

Following the announcement that Rep. Henry Waxman, D-Calif., intended to retire, the Generic Pharmaceutical Association bid adieu to a legislator who had a tremendous positive impact on the generic industry.

WASHINGTON — Following the announcement that Rep. Henry Waxman, D-Calif., intended to retire, the Generic Pharmaceutical Association on Thursday bid adieu to a legislator who had a tremendous positive impact on the generic industry. 

January 29, 2014

A call to make 2014 a year of action and for the government to work on behalf of Americans was the underlying theme of President Obama’s State of the Union address Tuesday evening.

WASHINGTON — A call to make 2014 a year of action and for the government to work on behalf of Americans was the underlying theme of President Obama’s State of the Union address Tuesday evening.

During his remarks, Obama touched upon a string of topics ranging from immigration reform, to education, to job creation. He also called for the raising of minimum wage and urged businesses to do what they can to raise employees’ wages, citing Costco as an example.

January 28, 2014

The Generic Pharmaceutical Association on Tuesday announced the hiring of Jonathan Marks as VP international affairs.

WASHINGTON — The Generic Pharmaceutical Association on Tuesday announced the hiring of Jonathan Marks as VP international affairs. Marks brings to GPhA more than 20 years of experience, including previous roles within the Department of Commerce. 

January 16, 2014

The U.S. House of Representatives on Wednesday voted to restore $85 million in Food and Drug Administration sequestered user fees.

WASHINGTON — The U.S. House of Representatives on Wednesday voted to restore $85 million in Food and Drug Administration sequestered user fees.

October 28, 2013

The last six drug take-back days sponsored by the Drug Enforcement Agency have collected nearly 2.8 million pounds of prescription drugs at more than 5,800 sites across the country, drawing praise from a drug industry trade organization.

WASHINGTON — The last six drug take-back days sponsored by the Drug Enforcement Agency have collected nearly 2.8 million pounds of prescription drugs at more than 5,800 sites across the country, drawing praise from a drug industry trade organization.

The Generic Pharmaceutical Association said it "strongly supports" the DEA's efforts, including the seventh annual National Prescription Drug Take-Back Day, which took place Saturday.

October 7, 2013

A trade group of generic drug makers is hoping that California's governor vetoes a bill that it says would restrict patients' access to biosimilars.

NEW YORK — A trade group of generic drug makers is hoping that California's governor vetoes a bill that it says would restrict patients' access to biosimilars.

September 27, 2013

A bill designed to strengthen the security of the drug supply chain by creating an electronic track-and-trace system and national standards for sterile pharmacy compounding has attracted support from trade groups representing independent pharmacies and generic drug makers.

WASHINGTON — A bill designed to strengthen the security of the drug supply chain by creating an electronic track-and-trace system and national standards for sterile pharmacy compounding has attracted support from trade groups representing retail pharmacies and generic drug makers.

September 12, 2013

The news that the Food and Drug Administration exceeded its hiring goals for a push that began last year to speed up review of generic drug approval applications is music to the ears of a trade group representing the industry.

WASHINGTON — The news that the Food and Drug Administration exceeded its hiring goals for a push that began last year to speed up review of generic drug approval applications is music to the ears of a trade group representing the industry.

June 4, 2013

The House of Representatives voted Monday to pass a bill that would establish national standards for the pharmaceutical supply chain.

WASHINGTON — The House of Representatives voted Monday to pass a bill that would establish national standards for the pharmaceutical supply chain.

May 30, 2013

This summer, the Supreme Court will decide on a case that could determine whether generic drug makers can be held liable when patients suffer harmful side effects from taking their drugs.

This summer, the Supreme Court will decide on a case that could determine whether generic drug makers can be held liable when patients suffer harmful side effects from taking their drugs.

May 29, 2013

Texas has become the latest state to defeat a bill that critics say would limit the reach of knock-off versions of biotech drugs.

WASHINGTON — Texas has become the latest state to defeat a bill that critics say would limit the reach of knock-off versions of biotech drugs.

May 13, 2013

The Generic Pharmaceutical Association has promoted Jason Money to associate VP federal government affairs, the trade group said Monday.

WASHINGTON — The Generic Pharmaceutical Association has promoted Jason Money to associate VP federal government affairs, the trade group said Monday.

Money, who has worked for the GPhA for six years, was previously the organization's senior director for federal affairs. In the new position, he will continue lobbying on behalf of the generic drug industry in Congress.

March 28, 2013

The generic drug industry's main trade group in Washington has hired a prominent lobbyist to head its government affairs team.

WASHINGTON — The generic drug industry's main trade group in Washington has hired a prominent lobbyist to head its government affairs team.

The Generic Pharmaceutical Association announced that it had hired Melissa Schulman as SVP government affairs, describing her as "one of the best known advocates" in Washington, noting her ranking as an influential lobbyist in publications such as Roll Call, The Hill and National Journal. Schulman previously worked as a Democratic lobbyist for the Bockorny Group.

March 21, 2013

Gov. Bob McDonnell of Virginia has signed into law the first bill that could limit the reach of follow-on biologics, though the bill includes a two-year sunset clause, meaning it will expire in 2015.

WASHINGTON — Gov. Bob McDonnell of Virginia has signed into law the first bill that could limit the reach of follow-on biologics, though the bill includes a two-year sunset clause, meaning it will expire in 2015.

McDonnell signed House bill 1422 and the identical Senate bill 1285, which would prevent a pharmacist from dispensing a biosimilar to substitute for the original, branded biologic if the prescriber indicated that substitution was not allowed or if the patient insisted on receiving the branded product.

March 8, 2013

While the Food and Drug Administration released draft guidance on regulations for biosimilars in February 2012, the final regulations have yet to appear. But already, everyone from analysts to trade groups to drug makers is preparing for a time when knock-off versions of biotech drugs will become available.

While the Food and Drug Administration released draft guidance on regulations for biosimilars in February 2012, the final regulations have yet to appear. But already, everyone from analysts to trade groups to drug makers is preparing for a time when knock-off versions of biotech drugs will become available.

A new report sheds light on some of the opportunities and challenges that exist in follow-on biologics, arguing that their opportunity to generate value depends on factors like the speed of development, clarity of regulation, ease of access and the roles of all stakeholders.

March 5, 2013

The stakes are high in a case involving generic drug maker Actavis and the Federal Trade Commission that will soon go before the Supreme Court, the head of a generic drug industry lobbying group said in a conference call with reporters Tuesday.

NEW YORK — The stakes are high in a case involving generic drug maker Actavis and the Federal Trade Commission that will soon go before the Supreme Court, the head of a generic drug industry lobbying group said in a conference call with reporters Tuesday.

The case, FTC v. Actavis, will go before the high court on March 25 and may decide the future of patent settlements between branded and generic drug companies. The Generic Pharmaceutical Association filed an amicus brief with the court last week defending the settlements as beneficial to consumers.

February 28, 2013

The battle over "pay for delay" continues to heat up, and its resolution likely won't come until the nation's highest court decides on the legality of the practice.

The battle over "pay for delay" continues to heat up, and its resolution likely won't come until the nation's highest court decides on the legality of the practice.

February 21, 2013

The Generic Pharmaceutical Association re-elected its chairman from last year and appointed a new board of directors for 2013 whose members run from A to Z — as in Amneal to Zydus.

ORLANDO, Fla. — The Generic Pharmaceutical Association re-elected its chairman from last year and appointed a new board of directors for 2013 whose members run from A to Z — as in Amneal to Zydus.

"We are grateful for the vision and support of the 2012 board of directors, and we are excited to move ahead with our chairman and our 2013 board," GPhA president and CEO Ralph Neas said. "In a time of enormous change and growth for our industry, leadership is critical."