President Trump continues to make good on his campaign promises. As I have previously re-ported, on January 20 President Trump’s chief of staff, Reince Priebus, ordered a freeze on regulations for all government agencies. This means that the FDA cannot send the two proposed regulations (Re-stricted Device and Amendments to the Performance Standard) to the Office of Management and Budget (OMB) for final approval until an official designated by the President reviews and approves the rules. This is important, because this new official creates another level of review at which we will be able to make our case against the rules should we find out there is movement.
Then on January 30, President Donald Trump signed another executive order, the purpose of which is to dramatically pare back federal regulations by requiring agencies to cut two existing regulations for every new rule introduced. This only affects proposed rules categorized as a “significant regulatory action.”
In its two sunlamp products proposed rulemakings, FDA only deemed the Restricted Device Proposed Rule a “significant regulatory action.” The Agency did not make a similar determination for the Performance Standard Proposed Rule. Before the Agency finalizes the Restricted Device Pro-posed Rule, the Office of Information and Regulatory Affairs (OIRA) at OMB must first review the final rulemaking and FDA must identify two existing regulatory actions to be repealed. OIRA is another pressure point at which we would have the opportunity to present our case against the proposed rule.
Most recently, on February 24, 2017, President Trump signed yet another executive order, “Enforcing the Regulatory Reform Agenda.” This particular order requires the head of each agency to designate an agency official as its Regulatory Reform Officer (“RRO”). Also under this Executive Order, each agency must also form a Regulatory Reform Task Force (“RRTF”). The RRTF “shall evaluate existing regulations and make recommendations to the agency head regarding their repeal, replacement or modification.” The Task Force must, at a minimum, attempt to identify regulations that eliminate jobs, or inhibit job creation. The Task Force will mainly be charged with reviewing potential deregulatory ac-tions in conjunction with any proposed rules going forward.
While there are no guarantees regarding how long these additional hurdles will delay the process, from our industry’s perspective, every additional bureaucratic barrier is good news.
From these actions, it is very clear President Trump and his team intend to reduce the impact of government regulations on businesses in all sectors of the economy. I feel certain that most individuals in this industry find this a welcome change after the past eight years.
Obamacare – Repeal and Replace … but When?
Even with the release on March 6 of the House GOP’s Obamacare repeal legislation, there is still no clear picture of what the final bill will look like after it passes both Houses of Congress.
The House Republicans’ bill would repeal large parts of the Affordable Care Act (ACA), including Medicaid expansion and the penalty for Americans who don’t purchase health insurance. The plan also calls for tax credits for purchasing insurance, shifting Medicaid payments for expanded coverage to more block-style grants for both individuals and state governments. Most importantly, almost all of the tax provisions from the ACA, including the Tan Tax, would be repealed.
While there is agreement among Republicans on reducing the cost of premiums, and empowering patients, there is serious disagreement on such issues as refundable tax credits for purchase of health insurance and expansion of Medicaid. Democrats are not likely to support any GOP-led measure, so the House Republicans must cobble together a majority for passage on their own. However, the President has signaled support for the House plan which will give it a significant boost.
At the present time, the goal is to complete House action by April and send the bill to the Senate where no one is certain what will happen. The Republicans only have a two-vote majority in the Senate and several GOP senators are already sending up warning flags.
I don’t expect final resolution of many of these issues to happen quickly. We should receive good news; but this debate could drag out into the summer and possibly beyond.
