21st Century Cures Act Lands in Federal Budget Blueprint

President Trump’s proposed FY 2018 Budget (a/k/a the “skinny budget”) presented a departure from his predecessor’s proposed annual budgets – namely a $54 billion increase in defense and military spending paired with corresponding cuts to virtually every other federal department. But one area President Trump did not cut was the implementation of the 21st Century Cures Act (the “Cures Act”), which also happens to be one of the last bills signed into law by then-President Obama. The FY 2018 budget blueprint proposes to appropriate $1.1 billion towards the Cures Act’s implementation in the upcoming fiscal year. The Cures Act strives to expedite the discovery, development, and delivery of new treatments and cures. Those in the medical, biotechnology, and pharmaceutical industry should look to the Cures Act as the potential game-changer that the bipartisan sponsors of the law hoped it would be. Not only does the Cures Act provide the National Institute of Health with significant new funds to speed up research into diseases like cancer and Alzheimer’s, but it also attempts to speed up the process by which new treatments are reviewed and approved by the FDA. The Cures Act also focuses on changes to the treatment of mental health and...

What You Need to Know About Federal Regulatory Reform

President Trump and the newly-elected Congress have made regulatory reform a main focus of their policy agenda. With Republicans controlling both the White House and Capitol Hill for the first time in over a decade, significant actions were taken within the first several weeks of coming into power that regulated industries should be aware of. Implementation of a Regulatory Freeze – The Trump Administration froze all federal rulemaking by issuing a policy memorandum to the Executive Branch departments and agencies. The memorandum declared that no regulations should be submitted “until a department or agency head appointed or designated by the President … reviews and approves the regulation.” The memorandum also required the Executive Branch agencies to either withdraw or postpone all agency regulations submitted to the Office of the Federal Register. The only exceptions to the regulatory freeze are for “emergency situations or other urgent circumstances relating to health, safety, financial, or national security matters” or “regulations subject to statutory or judicial deadlines.” Reducing Regulations for Domestic Manufacturing – President Trump directed the Executive Branch departments and agencies to support the expansion of manufacturing in the United States through “expedited reviews of and approvals for proposals to construct or expand...

Attorney-Client Protections Do Not Extend to Lawyers Providing Government Affairs Counseling in Non-Law Firm Settings

A December 10, 2015, joint decision from the Advisory Committee on Professional Ethics and the Committee on the Unauthorized Practice of Law (‘Committees’) provides clarity to lawyer-lobbyists working in non-law firm settings. Both Committees examined this issue after receiving an inquiry whether an attorney representing clients at a lobbying and government affairs services company that is not a law firm may use the designation “Esq.” after her name on company letterhead. The decision concludes that a lawyer may “associate with non-lawyers in lobbying and government affairs services companies, outside a law firm, provided the company communicates to their customers that they do not provide legal services or offer the protections of a lawyer-client relationship and the lawyers do not hold themselves out as acting in the capacity of lawyers.” The decision also directs attorneys, working in a non-legal setting, to not use the “Esquire” or “Esq.” designation. As part of its analysis, the Committee on the Unauthorized Practice of Law determined that many of the activities associated with lobbying are the practice of law, but also determined that it is in the public interest to allow registered non-lawyers to provide these services as well. They felt that “potential harm was...