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Enforcement Delays: A Tricky Balance for FDA

Posted 26 March 2018 | By Zachary Brennan 

Enforcement Delays: A Tricky Balance for FDA

Since FDA Commissioner Scott Gottlieb took over as the head of the agency last May, more than a half dozen rulemakings and enforcement deadlines have either been delayed or put on the back burner indefinitely because of pharmaceutical and medical device industry pressure, logistical concerns or both.

And though generalizing about a deeper meaning behind such delays across the board is difficult – some may stem from legitimate concerns that the initial deadlines were not feasible or that they were overly burdensome to comply with – the agency does seem to be favoring delays rather than making difficult decisions.

For instance, back in 2015, FDA launched a new voluntary quality metrics reporting program on drug and biologic manufacturing to better monitor quality control systems, processes and drive continuous improvements.

But following industry pushback on the idea and its associated costs, as well as FDA’s indication that it might make the program mandatory rather than voluntary, FDA said last December that it would not open its portal for metrics reporting, but it never explained why.

Similarly, on two other controversial topics – a rulemaking on generic drug labels and FDA’s regulation of lab-developed tests (LDTs) – plans for action have lingered for years, but no new updates have been announced on FDA’s direction.

For LDTs, FDA in 2016 drafted guidance to better regulate the tests, but then the agency decided to hold off on finalizing the document, which has not been touched on since. And the generic drug labeling rule has been around in a proposed form since 2013 but is no longer listed on FDA’s latest list of rules that are coming.

Other delays, including one on parts of an intended use rule, seem to have been spurred by unintended consequences, while FDA has not indicated a specific cause for other more recent delays to enforcement deadlines.

For instance, last week, FDA said it does not intend to enforce portions of a final rule related to postmarket safety reporting requirements for combination products, while in January FDA delayed its enforcement of certain unique device identification (UDI) system requirements for class I and unclassified devices by two years.

Since issuing the final UDI rule in 2013, FDA also pushed back compliance dates for other devices in response to concerns from companies over meeting deadlines or to address specific technical challenges.

Similarly, last June, FDA delayed by one year its enforcement of a requirement that certain drug manufacturers affix or imprint product identifiers to better track and trace drugs through the supply chain.

FDA also gave drugmakers an additional year, or until 5 May, before requiring drug master files and biological product files be submitted in electronic common technical document format.

Each situation is unique and the sum total may not add up to anything more than the federal government's slow bureaucracy, particularly as companies can sometimes wait for years between when a guidance document is drafted and then finalized.

And though the push back of such deadlines does not align with President Donald Trump's claims that he would cut 75% to 80% of FDA regulations, the delays do contrast with FDA's actions over at least the last eight years, as the agency had previously sought more comments or held meetings to discuss subjects that elicited a lot of opinions.

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