Susan Haigney is lead editor of Pharmaceutical Technology and Pharmaceutical Technology Europe.

Susan Haigney

	FDA has pushed back goals in relation to the Prescription Drug User Fee Act (PDUFA), the Biosimilar User Fee Act (BsUFA), and Medical Device User Fee Act (MDUFA) as a result of the closing of agency offices during Hurricane Sandy. FDA says it will assess the goals that were due October 31 and extend them as needed. The extensions will be no more than the number of business days the agency was closed.

 that it does not anticipate the need to extend goals for all applications under review and it anticipates that many applications will not require an extension. Certain applications sent that would have been received during the agency’s closure may “present issues regarding calculation of applicable review or regulatory clocks.” FDA asks that sponsors contact the review division or office responsible regarding submissions filed on October 29th or 30th.

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FDA has pushed back goals in relation to the Prescription Drug User Fee Act (PDUFA), the Biosimilar User Fee Act (BsUFA), and Medical Device User Fee Act (MDUFA) as a result of the closing of agency offices during Hurricane Sandy.

FDA Assesses Goals due to Hurricane Sandy

	The recent presidential and vice-presidential debates have highlighted the need for strategies for economic growth in the US, including the roles innovation and trade play in stimulating the US economy. Eli Lilly Chairman, President and CEO John C. Lechleiter recently weighed in on the issue with respect to the pharmaceutical industry in offering his perspective on the importance of including data exclusivity provisions for biologics as found in US law for the Trans-Pacific Partnership (TPP), a regional free trade pact in Asia under negotiation.

	Emphasizing America’s advances in innovation over the past two centuries, Lechleiter asks in an

, “how [do we] best sustain America’s capacity for innovation in the face of accelerating global competition?” Lechleiter believes the TPP is a vital channel that will lower barriers among nations, boost investment, and broaden the reach of products and services. Investors, according to Lechleiter, will be “more likely to risk ample capital…if they know that the markets for the products that follow are large and welcoming.” Also, emphasizing the importance of job growth, Lechleiter points out that the biopharmaceutical industry “supports some four million American jobs” that spurs biomedical research and has “kept us in a position of global leadership in this important sector. The TPP can expand America’s capacity for innovation, help create jobs here at home, and extend the reach of life-saving medicines to patients everywhere,” says Lechleiter.

	In welcoming the benefits of free trade, however, Lechleiter also raised some concerns in considering the TPP. Lechleiter stresses the need for strong intellectual property protections, citing the US’s Affordable Care Act, and believes that nations involved in TPP should commit to a 12-year data protection period similar to US law.  He believes the US and other countries involved in TPP negotiations will set the standards for countries, such as China, that are not part of the agreement. “We cannot sacrifice the fundamental incentives that drive biomedical R&D investments,” he says in the op-ed piece.

	Looking to improve access to the Asia-Pacific Economic Cooperation (APEC) group market, the US is participating in the TPP along with more than 10 other countries. Canada and Mexico recently joined the trade talks earlier this month. The US Chamber of Commerce has 

 that the TPP “represents a vital opportunity to ensure that American exporters have access to the world’s most dynamic economies” and recommends that negotiations exclude no products or sectors, establish strong intellectual property rules, break regulatory barriers, and create due process on antitrust enforcement.

	As the pharmaceutical industry continues to globalize and new markets become increasingly important for industry growth, balancing free trade and innovation and safeguarding intellectual property make for sound policy.

The recent presidential and vice-presidential debates have highlighted the need for strategies for economic growth in the US, including the roles innovation and trade play in stimulating the US economy.

Eli Lilly Chairman Stresses the Importance of Biopharmaceutical Innovation on the Economy

 October issue) raises that very question.  Earlier this year, the 

 reported that FDA had tracked employee emails in its investigation into the possible leak of agency information by FDA scientists who complained about the agency’s medical device review process. These scientists raised concerns about radiation danger levels.

	This situation is disconcerting on a few levels. First, and most important in my opinion, is the initial problem of a potentially faulty review process that may have allowed unsafe medical devices to reach patients. Second, and certainly a concern for manufacturing companies, is the potential leak by FDA employees of confidential data that had been submitted to FDA with the assurance that it would stay within the agency. And third, is the fact that a government agency may have violated the private correspondence, some of which may be protected under whistleblower laws, of its employees.

	Were the FDA staff members who allegedly leaked confidential company data right for doing what they did? Pharmaceutical companies rely on FDA to protect confidential scientific data that may be crucial to their future business; however, employees should feel safe to express important concerns. Ultimately, it is FDA’s job to protect health. It’s a sticky situation that should be addressed.

	Does FDA need to have a better system in place for employees to voice concerns while also protecting confidential data?

An upcoming PharmTech Viewpoint article (Check out PharmTech’s October issue) raises that very question.

Is FDA putting your company’s confidential data at risk?

	In 2008, adverse affects and deaths linked to Baxter’s blood thinner drug heparin revealed contamination in the heparin supply chain originating from an API manufacturer in China. FDA identified oversulfated chondroitin sulfate (OSCS) in the contaminated heparin. In response to the 2008 heparin situation, the United States Pharmacopeia Convention (USP) has revised the quality standards for heparin. Anita Szajek, PhD, and Tina Morris of USP highlight USP’s revisions to the heparin sodium monograph in the September 2012 issue of 

In 2008, adverse affects and deaths linked to Baxter’s blood thinner drug heparin revealed contamination in the heparin supply chain originating from an API manufacturer in China. FDA identified oversulfated chondroitin sulfate (OSCS) in the contaminated heparin.

USP Updates Heparin Sodium Monograph

As a result of the passage of the Generic Drug User Fee Amendments Act (GDUFA), Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) stated, in a Sept. 7, 2012 memorandum to CDER staff, her plan to reorganize the Office of Generic Drugs (OGD) into a “super office” that would include subordinate offices. The new super Office would report directly to Director Woodcock, with Greg Geba, MD, continuing his role as OGD director.

Another related proposal is to creation of an Office of Pharmaceutical Quality (OPQ) that would oversee quality throughout a drug’s life cycle. This office would take on some of the functions of the Office of Pharmaceutical Science (OPS). Woodcock also proposes aligning some functions of the Office of Manufacturing and Product Quality (OMPQ) into the new OPQ. OMPQ enforcement and compliance functions with remain in the Office of Compliance.

“All of these changes would be part of our ongoing efforts to ensure that CDER’s organizational structure supports our mission to ensure safe, effective, and high-quality drugs for the public," Woodcock stated. "As a regulatory agency, we want the public to be confident that we are successfully dealing with the global economy that is constantly adding more players, more technologies, and more complexity. I believe these organizational changes would give us the foundation we need to meet these new and ever-changing challenges.”

Woodcock stated there would be additional structural changes to come that will “sharpen our focus and bolster our resources around pharmaceutical quality. Quality is the underpinning of everything we do, and it is imperative that we have a drug quality program as robust as those programs we presently have for drug efficacy and drug safety.”

As a result of the passage of the Generic Drug User Fee Amendments Act, Janet Woodcock, director of the Center for Drug Evaluation and Research, announced her plan to reorganize the Office of Generic Drugs (OGD) into a super office that would include subordinate offices. The new super office would report directly to Director Woodcock, with Greg Geba continuing his role as OGD director.