Have pity on the regulatory professional.
Even under normal circumstances, the job of a regulatory professional-both those in government and in industry-is notoriously difficult, with long hours and highly complex and regulated material to work through.
But even as pipelines have dried up and the stakes of regulatory approval have increased, regulators are dealing with one other challenge that has mostly flown under the radar: a parade of new legislative requirements.
Since 2010, regulators have been subject to no fewer than six major pieces of regulatory legislation and dozens of other attempts to legislate various parts of the healthcare product regulatory system.
2011-12: PPACA, FSMA
2010 was of course marked by the landmark passage of the Patient Protection and Affordable Care Act (PPACA). While the law, also known as Obamacare, has been better known for its insurance provisions, it also instituted an approval pathway for so-called "biosimilar" products.
Those provisions, contained within the Biologics Price Competition and Innovation Act (BPCI) section of the law, set off massive changes within the biologics regulatory space as regulators and industry have grappled with everything from approval requirements and substitution standards to naming conventions and the right to challenge patents. Even more than three years later, all of these issues remain in a state of flux.
2011 saw the implementation of another major piece of legislation, the Food Safety Modernization Act (FSMA). While many of the law's provisions deal with produce, it also contains several which deal with dietary supplement manufacturers through its Foreign Supplier Verification Program (FSVP) requirements.
2012: The Year of FDASIA
2012 was a bigger year still, as legislators combined a number of smaller bills into the massive Food and Drug Administration Safety and Innovation Act (FDASIA). The bill can essentially be broken down into two parts: User fees provisions and various changes to how FDA operates.
For the former, FDASIA instituted two new user fee programs for biosimilars (BSUFA) and generic drugs (GDUFA), while dramatically increasing user fee rates for medical devices (MDUFA) and instituting new requirements under the longstanding prescription drug user fee program (PDUFA). Contained within each user fee program is a subset of new requirements, such as electronic filing requirements for pharmaceuticals and guidance documents required from FDA by set dates.
The latter part of the program contained a wide range of reforms, including a new approval pathway for antibiotics (the Generating Antibiotic Incentives Now Act, or GAIN Act), a new breakthrough product designation pathway, efforts to curb drug shortages, and pediatric testing incentives. Nearly all were formerly independent pieces of legislation before being rolled into FDASIA.
2012 also saw the passage of the SAFE DOSES Act, which served to increase financial and legal penalties for those who steal or knowingly pass on counterfeit medical products.
2013: Smaller Bills, More of Them
If you thought that FDASIA would satisfy legislators' desires for FDA-related legislation for a few years, you thought wrong. 2013 has proven to be a yet another big year for regulatory legislation, with several major pieces seeing passage.
The year began with the passage of budget sequestration measures that saw FDA lose hundreds of millions in both appropriated funding and user fee funding. For regulators who had helped to see FDASIA passed just months before, the development was particularly alarming, as FDA was now saddled with new responsibilities but lacked access to its promised funding.
Veterinary regulatory professionals saw the passage of the Animal Drug and Animal Generic Drug User Fee Reauthorization Act (ADAGDUFRA)in June 2012, marking the reauthorization of user fee programs for both innovative and generic animal drugs. The legislation altered user fee rates and instituted some changes in a commitment letter, but was otherwise free from add-ons.
In March 2013, President Barack Obama signed into law thePandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), which contained measures aimed at making it easier for FDA to approve products for emergency situations like a potential epidemic of a serious disease. Previously, FDA needed to wait until the disease was actively circulating in the US before being able to grant emergency conditional approvals.
And most recently, legislators passed-and the president is expected to soon sign-the Drug Quality and Security Act, which contains measures intended to institute a nationwide pharmaceutical track and trace system, as well as new requirements for pharmaceutical compounding entities.
What does it All mean?
All of which is to say, regulatory professionals have a lot of new requirements to deal with no matter what type of product is in their regulatory portfolio.
Some pieces of legislation, like FDASIA, single-handedly have a huge number of effects that are still in the process of being finalized and implemented. Others, such as PAHPRA, are narrower in their impacts, and will affect only a small subset of companies.
Even still, it's hard to recall a period in which so many pieces of major legislation have gone through in such a short amount of time.
Not since the early 2000s when the Best Pharmaceuticals for Children Act of 2002, Medical Device User Fee and Modernization Act of 2002, Bioterrorism Act of 2002, Animal Drug User Fee Act of 2003, Pediatric Research Equity Act of 2003, Minor Use and Minor Species Animal Health Act of 2004, Project BioShield Act of 2004 and the Food Allergen Labeling and Consumer Protection Act of 2004 were passed has there been such an interest by regulators in passing legislation related to FDA's regulatory processes.
And we should note that our list of recent legislation only contains mention of the bills that were passed into law. We omitted reference to more than a dozen pieces of legislation that were introduced but have not yet been passed into law, either for lack of interest, support or time.
And if recent evidence is any indication, more issues seem poised to generate attention, with House legislators now on their third round of hearings on FDA's regulation of mobile applications and healthcare-related software. One piece of legislation, the SOFTWARE Act, seems likely to see a vote in the coming months, and a wide range of other issues-the safety of medical devices, labeling changes for generic drugs, and others-are regularly raised by members as well.
So at a time when regulatory professionals in industry and government are being asked to do more with less, they're also being asked to understand more. With new opportunities, threats and requirements abound. And if the past is any indication, it may be years, or even decades, before the full impact of the legislation passed in the last few years is truly understood and felt.
In the meantime, regulatory professionals have a lot of legislation-and a lot more regulations and guidance documents-to read through.