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قديم 2016-06-10, 04:10 AM
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افتراضي Modernizing the Other Side of the Counter: FDA Oversight of Nonprescription Drugs



People in the U.S. have access to a wide variety of over-the-counter (OTC) drugs that enable them to self-manage a multitude of conditions. OTC drugs are available to prevent the effects of sun exposure (sunscreens), treat headaches or musculoskeletal pain, deal with minor infections, manage dandruff, and treat many other conditions, all without a visit to the doctor. The ability of consumers to prevent or care for minor health problems mitigates burden on the overall health care system. OTC drugs are widely used, with retail sales in 2015 estimated at above $32 billion. Approximately 800 active ingredients are approved for some 1,400 indications, and over 300,000 unique OTC drugs are currently on the market.

The Food and Drug Administration’s challenge in regulating all these OTC drugs is accordingly formidable. Beyond the sheer numbers, OTC drugs, which are used by consumers without the supervision of a health care professional, require a very high safety bar that takes into consideration the potential consequences of inappropriate use, the ability of the consumer to self-diagnose reasonably accurately, and the expected effectiveness under OTC conditions. Resources to ensure public accessibility—now and in the future—to safe and effective OTC drugs will be the focus of an upcoming public meeting on June 10, 2016 (see the link for a live webcast of the meeting).

The History of OTC Product Review

The current system for the regulatory review of OTC drugs at the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) was created administratively in 1972. At that time, the FDA faced the enormous task of applying drug product effectiveness requirements, as stipulated by the Kefauver-Harris Amendments of 1962, to the review of over 100,000 then-marketed OTC drugs. Rather than requiring the submission of 100,000 product-specific New Drug Applications (NDAs)—a prospect that would have severely disrupted the availability of self-care drug products in the U .S.—a system of active-ingredient–specific OTC monographs was designed (both regulatory systems—the OTC monograph system and the NDA review option—continue to be used today for the oversight of OTC drugs within CDER).

From among the entire array of OTC drugs in use in the early 1970s, active ingredients were divided into 26 broad therapeutic categories. Expert panels were convened to analyze whether each active ingredient could be “generally recognized as safe and effective” (i.e., GRASE). The resulting monographs specified indications for appropriate self-care use (e.g., headache or diaper rash) and established the conditions (e.g., permissible concentrations) under which ingredients could be incorporated into the ongoing manufacture of OTC drugs. The OTC monograph system proved to be of great value in removing ineffective and unsafe products from the market and in ensuring that a wide selection of self-care options remained available to the millions of American consumers who had come to depend on them.

Systemic Hurdles and OTC Monograph Review

Unfortunately, over the course of its five decades of existence, our OTC review system has come to distinguish itself in problematic ways from other drug review programs within CDER. It is one of the largest and most complex regulatory programs ever undertaken by the FDA. More to the point, the system is built on an inefficient rulemaking process that is enormously time-consuming, requiring multiple steps and imposing considerable administrative burdens. Many monographs that originated decades ago have still not been finalized, in part reflecting a great limitation in FDA’s review resources. In the CDER division that is responsible for OTC monograph review (as well as for OTC drugs reviewed under new drug applications), there are currently only 18 full-time employees allocated to monograph review work.

And clearly, we would like to be able to do more than merely maintain a system that originated a half-century ago. Science by its very nature cannot be static, and we want to be able to usher advances in drug formulation and emerging safety data into the OTC product arena promptly. Our current system of OTC review is simply too sluggish to promote OTC modernization. If we count only those monograph drugs that are currently in non-final status, it will take many decades, under current conditions, to produce finalized monographs. In addition, this hopelessly slow time frame will be possible only if we ignore opportunities for improving the effectiveness, safety, and quality of existing OTC drugs that are on the market.

Learning from Prescription Drug Success Stories

We have seen great changes in the regulatory oversight of prescription drug products in recent years, owing to the concerted efforts and judicious planning of many stakeholders. The implementation of statutory user fee programs within CDER has played a particularly important role. User fee programs have greatly improved the transparency, timeliness, and flexibility of prescription drug product review, to the great benefit of our patients as well as industrial stakeholders. User fee programs implemented at CDER address review programs for novel small-molecule, generic, and biologic drug products. We have every reason to believe that comparable advances in the OTC drug space could be achieved if the appropriate user fee program were developed.

At a meeting held by the FDA in the spring of 2014, we heard comments from stakeholders that urged better program management practices on the part of the FDA in overseeing OTC drugs, a point that we have taken to heart. But with millions of consumers each year making use of hundreds of thousands of OTC drugs, better program management practices alone cannot come near to meeting the challenges we face, and the FDA does not currently have the resources to modernize its OTC review practices. The Consumer Healthcare Products Association (CHPA) has provided important leadership for exploring challenges in the development and regulation of OTC drugs.

The upcoming public meeting to further discussion about the possibility of an OTC user fee program is an opportunity for all stakeholders in OTC drug product development to provide their views and contribute to this very important area of public health care. It is crucial that an OTC monograph user fee program be considered in a broader context that addresses FDA review practices, the needs of consumers, and the commitment of industry.
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