Regulatory Focus™ > News Articles > Hamburg: Quality one of FDA's 'Highest Priorities' in 2013, Agency Creating New Quality Office

Hamburg: Quality one of FDA's 'Highest Priorities' in 2013, Agency Creating New Quality Office

Posted 25 February 2013 | By Alexander Gaffney, RAC

In a wide-ranging speech before the Generic Pharmaceutical Association's annual meeting in Florida, US Food and Drug Administration (FDA) Commissioner Margaret Hamburg said her regulatory agency will be placing an increased focus on quality issues in 2013, noting its integral role in recurring drug shortages and other problems.

The generics industry, Hamburg said, is "playing an increasingly central and transformative role in our nation's health care system," adding that 85% of all prescriptions filled in the US are generics.

But even as it steps up to the plate to provide huge savings to the American consumer-by Hamburg's estimation, more than $1 trillion since the passage of the Hatch Waxman Act, it's regularly falling short in one area of particular concern: Quality.

"Year in and year out, we say much about safety and efficacy," said Hamburg. "But without product quality, none of us can feel confident that the product will be either safe or effective. These concepts go hand in hand.  And unfortunately, we've seen far too many quality lapses throughout the pharmaceutical industry over the past few years."

Focus on Generics

And while those concerns aren't exclusive to generic drugs, there have been a troubling number of alarming lapses that have caught the attention of FDA, Hamburg explained.

"That's why we've chosen to make quality one of our highest priorities this year, and we'd like you to do the same," she said.

Hamburg noted that quality products, even beyond being essential to ensuring that consumers aren't subjected to harm, are essential to a company's reputation as well. "It takes time to build your reputation, but unfortunately, it takes only a few lapses to potentially damage it," she noted.

"Quality is the basis of the public's confidence in pharmaceuticals […] and confidence in the high quality of products being produced at American facilities is what has helped to make the U.S. pharmaceutical industry the gold standard for the world."

This is a particularly prescient problem for the generics industry in general, observed Hamburg, as both the industry and FDA have repeatedly been forced to try to persuade a sometimes skeptical public that generic drugs are no less safe and just as effective as their brand name counterparts.

Both of their gains among the public can be quickly undone if the industry doesn't match reality to rhetoric, she said.

"Quality is the foundation on which everything else must rest," Hamburg continued. "But instilling quality is equally important for your future pipeline as well.  As we see increased numbers of marketing applications for new innovator and generic drugs, including more complex dosage forms and delivery systems, the need for greater focus on quality is all the more imperative."

Changes to be Made

This increased focus on quality will not come in the form of new requirements, but rather in the form of a new emphasis on existing good manufacturing practice (GMP) standards, Hamburg said.

However, FDA will be launching at least one new thing: a new Office of Pharmaceutical Quality, which Hamburg said will aim to "address the increasing complexity of products [and] optimize the use of staff talent and review expertise to improve consistency and regulatory certainty across the wide span of drug quality review."

The commissioner also said the agency is working to put into place continual quality surveillance systems that will allow the agency to detect early on whether drug products are meeting the appropriate standards. "This will make it possible to detect issues early enough so that steps can be taken to prevent patient harm and avert shortages," she said.

"Instilling and maintaining quality is a formidable challenge, but I have no doubt that your companies are capable of meeting this challenge," Hamburg concluded. "If done right, FDA will have a great ability to recognize those companies that seek and maintain quality products - and to focus appropriate attention on those that don't."

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