I guess this is the next step in the evaluation of what we can expect regarding proposals for future regulations. Semiannual regulatory agendas, along with tentative timetables, are published twice a year (as the name implies) to outline regulations that each agency is planning on issuing for those regulations.
Today, in the pre-publication of the FR notices (here), twenty-four different regulatory agendas from twenty-four different agencies were listed as withdrawn, including the regulatory agenda from the Department of Health and Human Services. In my view, this means that the Administration will be performing a top-down evaluation of each of the Agency agendas, which likely will either be trimmed down considerably or eliminated outright.
This could have a chilling effect on how the FDA conducts business through the regulatory process as it is through regulations that the Agency provides its interpretation of the statutes that Congress passes. The regulations provide stakeholders with a good idea of Agency expectations. From a stakeholder’s perspective, I like having regulatory clarity as it creates certainty for industry, especially in the pharmaceutical space. While there are those who argue that there are too many regulations and then complain when they get a letter from FDA explaining why they are receiving a Complete Response Letter or other Agency action, they can look to the regulations to see whether there is support for the Agency’s action. They may challenge the FDA’s interpretation of a regulation, but at least they have a starting point for disagreement.
With the 10-for-1 rule (eliminate ten old rules for each new one) getting a new regulation through the process isn’t going to be a walk in the park, especially if there are not enough old, outdated regulations on the books to remove. Back at the time of the passage of Hatch-Waxman, industry (as well as Congress) harshly criticized the FDA for taking five years to get the proposed Hatch-Waxman regulations published, then another three years to finalize the ANDA portion of the rule, and yet another two years for the final patent and exclusivity provisions to be published. Yes, a total of ten years to finally set the entire table for the “how, what, and why” for generic drugs.
If Congress continues to pass legislation, which, by the way, is its job, the agencies of the government must let stakeholders know what the expectations are, which is usually done by regulation. While agencies can use guidance documents to a certain extent, most statutes passed by Congress have a timetable for the respective agency to publish regulations implementing the statute.
Well, we will see what becomes of the regulatory agendas and how each agency will deal with letting stakeholders know what they need to know in order to comply with new legislation and how to effectively do business with the respective government agency. Right now, there is not much clarity—perhaps we need a regulation for that!
