Life Science Compliance Update

June 27, 2016

Senators Send FDA Letter with Concerns Over Draft Guidance Documents

Four United States senators sent a letter to United States Food and Drug Administration (FDA) Commissioner Robert Califf with concerns over the agency's apparent inability to revise, finalize, or withdraw draft guidance documents in a timely manner. The letter notes that on average, it takes between 425 and 797 days to finalize a draft guidance.

The comments echo comments that have been made at various Congressional hearings with myriad FDA officials, and stem from industry and physician complaints over the agency's use of draft guidance in carrying out regulatory responsibilities, particularly among those who "feel no choice but to follow draft guidances as if final, even if the most-up-to-date science would suggest an alternative path."

The letter comes a few months after the FDA's Center for Drug Evaluation and Research's (CDER) 2016 guidance agenda. The agenda outlined an increase in issuance of such guidance, with a total of 102 guidance documents set to be released this year. The number of planned guidance documents issued shows a steady incline: from 60 in 2013, 70 in 2014, and 90 in 2015.

The four senators, Lamar Alexander, Richard Burr, Johnny Isakson, and Orrin Hatch, take issue with the fact that on average, it takes the FDA over a year (sometimes over two years) to finalize draft guidance. Additionally, the FDA has been sending letters to industry with regard to "new thinking" by the agency that can only be found in draft guidance documents.

However, the senators did praise the FDA for using a new, more transparent website to list newly-issued guidance documents and for the withdrawal of forty-seven "outdated and unfinished" documents last May.

The bulk of the letter focused on requests by the senators, including an update on the stat that it takes between 425 and 797 days to finalize a draft guidance.

The letter also requests an updated list that identifies each draft guidance document that was published before December 31, 2015, and still is pending; an update on the plan for each Center and Office that "are continuing to work on their plan for which guidances will be withdrawn, reissued, or finalized;" whether or not the Agency plans to require Centers and Offices to systematically review guidances and withdraw, revise, or finalize those outstanding documents in a timely manner.

The letter also reiterated some concerns about how the Agency ensures that staff do not follow the guidance in the absence of any other policy or final guidance. The Agency has previously indicated that it provides initial and ongoing training for employees about how to develop and use guidance documents. The Senators asked for a "detailed description of who conducts these trainings, how frequently they occur, and the content and forum of the trainings. Please also provide copies of all training materials, including notes from presenters, slides or videos, and any review of the effectiveness of such training by the FDA or a contractor."

In a March 2015 response, the FDA stated that staff may sometimes reach the same results as proposed in a draft guidance when applying statutes and regulations, explaining that "[a] draft guidance reflects FDA current thinking, and thus also usually reflects its current interpretation of the statute and regulations." However, the Senators are a little concerned that when the FDA publishes a draft guidance, it includes a statement that the draft guidance document will represent the Agency's current thinking only "when finalized." The letter requests clarification as to whether a draft guidance which has not been finalized should be construed as expressing the FDA's current thinking.

The FDA has not yet responded to this letter. When the senators sent a similar letter in May 2014, the Agency took almost an entire year to respond, writing back in March 2015.

June 23, 2016

FDA Holds Public Meeting on Monograph Fees

The United States Food and Drug Administration (FDA) has announced that it will start to gather information on creating a new user fee program for nonprescription, over-the-counter (OTC) drugs. The user fee program would provide funding to supplement congressional non-user-fee appropriations, and would support timely and efficient FDA review of the efficacy and safety of ingredients included in or proposed for inclusion in a monograph.

A monograph is a kind of "recipe book," covering the acceptable ingredients, doses, formulations, and labeling for OTC drugs. Sponsors of OTC drugs that rely on monographs are not required to seek FDA approval prior to marketing a product under a monograph. According to the FDA, "the OTC monograph process is ingredient-based, as opposed to product-based, and is done through a multi-step public rulemaking process. The monograph allows industry to market a drug product that contains a monograph ingredient as long as the manufacturer complies with all applicable regulations, including the conditions of the monograph."

However, lately, due to a lack of resources, finalization of OTC monographs has been slow in many therapeutic areas, with the result that there are OTC drugs currently on the market with still-pending monographs and for which the FDA has not made the final determination of safety and effectiveness.

The FDA currently has eighteen full-time employees that are devoted to overseeing the OTC market, which is typically the same number of employees it takes to review one novel prescription drug application.

According to the Agency,

The FDA estimates that at the current funding level, it would take multiple decades to review and finalize the spectrum of drug monographs that are currently in non-final status. Because the FDA prioritizes activities by public health need, it is likely that, in the absence of additional funding, most of the FDA's monograph review resources would need to go toward addressing urgent safety issues, with definitive action on the general safety and effectiveness of non-final monograph drugs and innovation review occurring only as strained resources permit.

On June 10, 2016, the FDA held a public meeting to gather stakeholder input on the development of the new user fee program for OTC drugs. The Agency sought input on (1) what types of user fees might be appropriate for a potential monograph user-fee program and (2) what types of performance goals might be important to consider from a public health and sponsor perspective? What parameters could be measured to gauge the success of a user-fee program?

Much of the meeting focused on background information on what a user fee program is and why it may or may not be necessary from economic and public health perspectives. Attendees of the public meeting heard from various FDA officials, including a panel on consumer perspectives, health care professional perspectives, industry perspectives, and scientific community perspectives.

Details of any specific user fee system were not really discussed at the public meeting, likely in part because the OTC monograph system is unique, the OTC market is a fraction of what the brand name, generic, biosimilar and medical device industries are, and that OTC drug companies may not see expedited FDA reviews of particular products, or financial benefits from a new system.

Dr. Diana Zuckerman of the National Center for Health Research suggested that the user fee program be structured as a sliding scale with product fees based on the amount of resources needed for FDA's review. Diane McEnroe of Sidley Austin suggested that her clients might favor a system where innovation is prioritized and that user fees should not be used to finalize pending monographs.

Jethro Ekuta with Johnson and Johnson offered support for the user fees, but also suggested that the FDA explore other sources of revenue. Cornell Stamoran of the Pharma and Biopharma Outsourcing Association recommended one-time licensing fees and small annual product fees for the monographs to be maintained, but no facility fees for the manufacturers. The CFO of Humco, Steven Woolf, however, recognized that the economic impact of a user fee system for OTC products will eventually be passed down to the consumer and such a concern should be at the top of their minds.

The Consumer Healthcare Products Association expressed cautious optimism on the impact OTC monograph user fees may have on OTC innovation. According to Barbara Kochanowski, the Vice President of Regulatory and Scientific Affairs,

Unlike other drugs subject to user fees, nonprescription drugs under the Monograph system are not subject to FDA approval prior to marketing. Many of these ingredients have been marketed for more than 40 years, with a long history of safe use. There is no backlog of applications. Therefore, we must define value differently than industries subject to FDA approval prior to marketing.

The FDA also put together a Frequently Asked Questions document on monograph user fees, which can be found here.

June 21, 2016

How the FDA Is Doing with Medical Devices and the Medical Device Industry

The FDA and the GAO both released data on the FDA's performance in medical device regulation over the last several years. This article takes a close look at this data and compares it with the data available through the FDA's OpenFDA database. The data shows recalls have increased, but postmarket and postapproval studies have declined.

The pharmaceutical industry's frustration with the pace of medical device approvals has been well-known over the years. Top executives routinely express frustration with the lack of speed of the regulatory process. According to a PwC survey published in early 2015, industry leaders indicated that they were open to regulatory reforms, including stricter post-market safety requirements and restrictions on promotional activities, to speed access to new treatments.37 Specifically, 71% of responders were willing to accept stricter post-market surveillance in exchange for more accelerated and predictable approval programs. The Government Accountability Office and the Food and Drug Administration issued reports on the FDA's performance in the medical device arena late 2015. So how is the Food and Drug Administration (FDA) doing concerning medical devices? By combining a review of the Government Accountability Office (GAO) study with the FDA's data, we find the picture to be mixed.

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