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David Gaugh, Senior Vice President, Sciences and Regulatory Affairs, GPhA, Remarks on GDUFA II

Contact: Steve Arnoff 202.249.7113 

WASHINGTON, DC (Oct. 21, 2016) —

As Prepared for the Food and Drug Administration (FDA) Generic Drug User Fee Amendments (GDUFA) II Reauthorization Public Meeting

“I am David Gaugh, Senior Vice President of Sciences and Regulatory Affairs at the Generic Pharmaceutical Association (GPhA) and a licensed pharmacist. GPhA represents the manufacturers and distributors of finished dose generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 88 percent of the prescriptions dispensed in the U.S. but consume just 28 percent of the total drug spending.

Today’s generic industry is one marked by diverse companies who have become global leaders both in providing equivalent medicines and in pioneering new treatment options for patients. Generic competition also continues to play a vital role in driving access to pharmaceuticals and cost savings to patients and the healthcare system. This growth in the generic industry has led to the creation of tens of thousands of new jobs across the country.

GPhA engaged in GDUFA II negotiations to continue building on the foundation laid by GDUFA I. Our goals were to ensure that the industry balances the safety of its products with improved patient access to generic products while improving the transparency of the drug review process by the Agency.

Key Goals Include
Safety – Ensure that industry participants, foreign or domestic, who engage in the U.S. generic drug system, are held to consistent high quality standards.

Access – Expedite the availability of reasonably-priced, quality generic drugs by bringing greater predictability to the review process for ANDAs, amendments and supplements.
• 8 month priority review of critical products. 10 month review for standard products.
• Complex products will need to supply early data in order to be eligible to receive enhanced communications opportunities to foster the increasing number of complex products that can be approved in a timely manner.

Transparency – Enhance FDA’s ability to protect Americans in the complex global supply environment. This will be achieved by requiring the identification of facilities involved in the manufacture of generic drugs – both finished dosage forms and active pharmaceutical ingredients, –and by improving FDA’s communications and feedback with industry in order to expedite product access.

• ANDA Review Transparency and Communications Enhancements – Increased transparency and communication between FDA and ANDA applicants throughout the review process. This will be accomplished by using Information Requests (IRs) and Discipline Review Letters (DRLs) to decrease the number of review cycles, post-CRL teleconferences with metrics, timely tentative approval conversion into full approval, and a dispute resolution process with definitive timelines.

• Reporting and Accountability – FDA will conduct increased financial and performance reporting to maximize transparency to industry and the public. Financial transparency and efficiency will be enhanced by FDA’s commitment to evaluate the financial administration of the GDUFA program and to identify areas to enhance operational and fiscal efficiency. Several key performance reporting requirements will ensure that levels of transparency and efficiency are maintained and will be released on a quarterly and annual basis.

Additional Resources to Expand Generic Access
Under the five-year GDUFA II program, the generic industry will provide the FDA with $2.6 billion in financial resources to help ensure Americans receive timely access to safe, effective and affordable generic drugs. These funds will be in additional to the Budget Authority funding provide by the Federal Government.

To function most effectively, and to promote the goal of achieving first cycle approvals and approvals on the earliest legally eligible date, industry focused during the negotiations on increasing transparency and communication during the review process. Maximizing the effectiveness of the review process requires the cooperation of FDA and the generic drug industry, both of which will benefit from sharing their knowledge and concerns throughout the review. The fewer review cycles to approval, the sooner patients and payors can experience the benefits of generic competition.”

About GPhA
GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 88 percent of the prescriptions dispensed in the U.S. but consume just 28 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on twitter: @gpha.