Better Access to Complex Generics: A Public-Private Collaboration Built on Transparency, Flexibility and Predictability

Americans are receiving a COVID-19 vaccine – only one year into a global pandemic. Such a breakthrough is unprecedented and can be largely credited to the sustained cooperation and innovation among scientists, clinicians, pharmaceutical researchers and manufacturers, government, and in particular, the U.S. Food and Drug Administration.

This level of collaboration is illustrative of public-private success from which FDA and the generic pharmaceutical industry can take lessons to accomplish other pivotal public health goals. One imminent opportunity is ensuring the timely approval of generic versions of complex medicines – therapies which include auto-injectors like EpiPen and inhalers used to treat asthma – that are critical to the care of many serious and chronic medical conditions.

There’s no debating the immense cost savings generics bring to the U.S. health care system, but the market for complex generics is unnecessarily and especially difficult to enter and sustain. Generics companies must attempt to factor in many unknowns over an extended period: legal, regulatory, market demand, operational investments such as manufacturing and positioning of other prescription and generic companies. The unpredictability of extensive regulatory reviews and approvals (some that stretch for years) coupled with regulatory uncertainties hinder the ability to adequately prepare in advance to launch these medicines.

All of these factors limit or delay patient access to more affordable medicines, ultimately impacting whether it is sustainable to continue developing complex generics, and costing the health care system billions of dollars. A new economic analysis found that accelerating the regulatory review process for complex generics could save the U.S. health care system $1.3 billion each year.

The first step to bringing more complex generics to patients faster is to improve the FDA review process through the reauthorization of the Generic Drug User Fee Amendments, which is intended to speed up FDA’s approval of new generic drugs, stimulate competition for branded drugs and reduce drug prices for consumers. Congress is set to reauthorize GDUFA in 2022, and adopting meaningful changes to GDUFA is an opportunity that cannot be missed.

Despite considerable goodwill and a strong desire on everyone’s part to correct inefficiencies, the dialogue between industry and FDA has been cumbersome. Both the agency and industry recognize that the regulatory system for complex generics requires more flexibility, transparency and predictability – characteristics that are often hard to reconcile with an FDA review process that predates the availability of newer, more complex generics.

Product Specific Guidances are a good example of this tension. On the one hand, the publication of nearly 1900 guidances has significantly increased predictability about the standards for approval of complex generic drugs. However, the guidances are treated as absolutes, and can even be retroactively applied to generic applications that have been developed over several years with FDA’s support. Greater flexibility is needed for these products to be approved and reach patients.

Because GDUFA III is currently under negotiation, the opportunity to increase the efficiency of the current review process is both large and immediate. For payers, complex generics are a large and significant opportunity for future cost savings. For patients, complex generics represent greater access to medicines that are just as safe and effective but cost much less. By adopting a spirit of cooperation and driving long-term reforms to the FDA review process, everyone stands to benefit – most notably the people who will benefit from greater availability of a wide-range of approved generic medicines.

Christine Baeder is SVP, chief operating officer for U.S. Generics at Teva Pharmaceuticals USA, Inc.

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