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Reports continue to affirm value of generics.

WASHINGTON -- The recent AARP report reviewing trends in generic drug prices highlights the value of generic drugs to America's seniors and the health care system, says Ralph Neas, president and chief executive officer of the Generic Pharmaceutical Association (GPhA).

"As the report notes, retail prices for generic drugs fell an average of 4% in 2013, marking nearly a decade of consecutive years of decreasing generic drug costs. The report also notes that 73% of generic drugs in the study experienced price decreases. The AARP report underscores that generic drugs remain significantly more affordable than costly brand drugs while being just as safe and effective," said Neas in a prepared statement.

"Similarly, the 2014 Express Scripts Drug Trend report notes that since 2008 the price of brand drags has almost doubled but the price of generic drugs has been cut nearly in half."

To further increase competition and improve patient access to affordable medicines, Neas urged policy makers to "encourage the timely approval of more than 3,000 generic drag applications awaiting approval from the Food and Drag Administration," adding that Congress can address the misuse of programs designed to protect patient safety such as Risk Evaluation and Mitigation Strategies (REMS), which Neas alleges some brand companies use to keep generic drags out of the market.

"A recent study by Matrix Global Advisors estimates that preventing this misuse could save $5.4 billion. Congress also can encourage the FDA to formalize a biosimilar approval framework and naming construct that encourages competition for these new versions of lifesaving biologies, noted Neas.

"These are just some of the policies that would enhance access, improve choices and generate billions in savings. Since the landmark passage of Hatch-Waxman in 1984, the industry's record of patient and provider savings is unquestionable. Moving forward, it is now more important than ever to ensure that the political and regulatory environment encourages rather than hinders the timely availability of safe, high-quality and more affordable generic drags," said Neas.

Separately, the GPhA executive elaborated on his comments regarding REMS when he applauded Reps. Steve Stivers (R., Ohio) and Peter Welch (D., Vt.) for introducing the Fair Access for Safe and Timely (FAST) Generics Act. This bipartisan bill would close loopholes that allow some drag companies to misuse REMS programs and other non-FDA-mandated restricted access programs to "thwart competition" from generic drags, said Neas.

"When used as intended, REMS programs are important for patient safety. The FAST Generics Act sets forth more explicit legal requirements and processes for the acquisition of product samples by generic and biosimilar developers, at the same time putting safeguards in place to protect public health," Neas explained.

"This legislation is vital to maintaining competition in the pharmaceutical marketplace and ensuring patient access to affordable, lifesaving medications."

On another critical topic, GPhA presented comments at an FDA meeting to discuss strengthening the agency's implementation of the Generic Drag User Fee Act (GDUFA). The generic drag industry funds 100% of this $1.5 billion program, now at its midpoint.

"It is industry opinion that the FDA is falling short of meeting its commitment to GDUFA goals, resulting in decreased access for patients and billions of dollars in lost savings. However, process changes and staff expansion over the past three years have set a promising foundation for FDA action. But, the results thus far leave much room for improvement," said Neas.

"The generic drag application backlog is more than 4,000 and growing, according to FDA data. And, as the backlog increases, median review times for generic applications are getting longer."

Neas noted that in 2011, when GDUFA began, median review time to approval was at 30 months. Since then, median review times increased to 31 months in fiscal year 2012, 36 months in FY2013 and an estimated 42 months in FY2014.
Average Annual Generic Drug
Retail Price Declines

2009      -8.7%
2010      -4.1%
2011      -9.1%
2012     -14.5%
2013        -4%

Source: AARP Public Policy Institute.

Note: Table made from bar graph.
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Title Annotation:Focus
Publication:Chain Drug Review
Date:Jul 6, 2015
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