ML Strategies
Viewpoints
Filter by:
Financial Relief for the Small Business Community in Massachusetts
March 19, 2020 | Blog | By Steven Baddour, Daniel Connelly, Caitlin Beresin, Kaitlyn Sprague, Taylor Shepherd
The Baker Administration, along with prioritizing the medial professionals on the front lines of the fight against the novel coronavirus (“COVID-19”), have taken significant steps to relieve pressures on small businesses negatively impacted by the virus. Most notably, opportunities through the Small Business Administration’s (“SBA”) Economic Injury Disaster Loan program and other tax relief for small businesses including those in the restaurant and hospitality sectors.
Read more
Congress Calls on FTC to Protect Americans from Price Gouging During COVID-19 Health Crisis
March 18, 2020 | Blog | By Christian Tamotsu Fjeld
On Wednesday, key Members of the House of Representatives sent a letter to the Chairman of the Federal Trade Commission (FTC), urging the Commission “to take immediate action to protect consumers from price gouging during this [COVID-19] declared public emergency.” The letter was sent to FTC Chairman Joseph Simons from the chairs of the committees and subcommittees with jurisdiction over the FTC:
Read more
FDA’s Ongoing Response to the COVID-19 (Coronavirus) Outbreak
March 18, 2020 | Blog | By Joanne Hawana , Benjamin Zegarelli
As we write this update on the actions of the Food and Drug Administration (FDA), more state and local governments (along with private businesses and employers) are taking sweeping actions to protect the public from the continued spread of COVID-19. The federal response to what is now a pandemic of COVID-19 started off slowly, but we are now seeing frequent and promising announcements from FDA and other agencies within the Department of Health and Human Services.
We published our first installment highlighting FDA’s role in this public health emergency on March 4, 2020 (see our prior post here). In the two weeks that have elapsed since then, FDA has taken several actions related to COVID-19 testing and other important public health protections which are explained below. One of the most striking things about the list of actions included in this post may be how diverse and broad FDA’s authorities are and what a substantial role the agency plays in protecting Americans from a variety of different types of harm.
Read more
We published our first installment highlighting FDA’s role in this public health emergency on March 4, 2020 (see our prior post here). In the two weeks that have elapsed since then, FDA has taken several actions related to COVID-19 testing and other important public health protections which are explained below. One of the most striking things about the list of actions included in this post may be how diverse and broad FDA’s authorities are and what a substantial role the agency plays in protecting Americans from a variety of different types of harm.
Massachusetts COVID-19 Update
March 16, 2020 | Blog | By Steven Baddour, Daniel Connelly, Caitlin Beresin, Kaitlyn Sprague, Taylor Shepherd
The Baker Administration continues to monitor the COVID-19 public health crisis, expanding almost daily on restrictions for schools, restaurants and several other places of business across the Commonwealth. As these updates are constantly evolving, this post is meant to provide the most up to date announcements.
Read more
COVID-19 Legislative Update - What Will Happen Between Now and July 31, 2020?
March 12, 2020 | Blog | By Steven Baddour, Daniel Connelly, Kaitlyn Sprague, Caitlin Beresin, Taylor Shepherd
As the nation continues to address the spread of the novel coronavirus (“COVID-19”), several precautionary efforts are being taken to ensure citizens remain safe and reduce the prevalence of transmission to vulnerable individuals across the country. As the Legislature and Executive Branch aggressively focus on COVID-19 related issues, your ML Strategies team will continue to monitor and engage state and local leaders on legislative and regulatory priorities by keeping lines of communication open on a daily basis with legislators and staff.
Read more
The VALID Act, Aiming to Reform the Regulation of Diagnostic Products, Is Finally Introduced in Congress
March 12, 2020 | Blog
Following years of discussion, on March 5, 2020, U.S. Representatives Larry Buchson (R-IN) and Diana DeGette (D-CO) and U.S. Senators Richard Burr (R-NC) and Michael Bennet (D-CO) introduced identical versions of the Verifying Accurate and Leading-edge IVCT Development (VALID) Act in both chambers of Congress. The bipartisan legislation closely tracks existing medical device laws, with some notable exceptions, discussed below and in a prior post. If enacted, many regulatory elements familiar to in vitro diagnostic (IVD) and other medical device manufacturers would be applied to clinical laboratories that develop their own tests, commonly known as laboratory developed tests (LDTs). The bill also includes elements that are priorities for the Food and Drug Administration (FDA), including a program conceptually similar to pre-certification, third-party review, and Collaborative Communities. Unlike previously-circulated discussion drafts, the introduced bills include specific language designed to address public health emergencies, including COVID-19.
Read more
FDA’s Evolving Response to the COVID-19 (Coronavirus) Outbreak
March 4, 2020 | Blog | By Joanne Hawana
Within the U.S. Department of Health and Human Services (HHS), many agencies have responsibility for responding to public health emergencies. The Centers for Disease Control and Prevention (CDC), as its name implies, is at the forefront of the COVID-19 (coronavirus) outbreak as the government seeks to control and prevent the spread of the virus in the United States. The National Institutes of Health (NIH), particularly the National Institute of Allergy and Infectious Diseases, are also involved, primarily conducting research into the sources, cause, and means of transmission of the new virus and coordinating vaccine development efforts. The Food and Drug Administration (FDA) is responsible for assuring the safety and effectiveness of medical products and therefore has oversight over any clinical trials for promising coronavirus treatments (drugs, vaccines, devices), as well as authority to authorize the marketing of any such product. The agency oversees the drug supply chain and monitors drug and device shortages. This blog post covers steps that FDA has taken to mitigate potential drug and device shortages related to coronavirus and to otherwise respond to the coronavirus situation.
Read more
Closing the Orphan Drug Act Loophole
February 18, 2020 | Blog
On Tuesday, February 11, 2020, Senators Bill Cassidy (R-LA), Jeanne Shaheen (D-NH), and Tammy Baldwin (D-WI) introduced legislation to eliminate the “orphan drug loophole.” Current law allows the Food and Drug Administration (FDA) to grant seven years of market exclusivity to a drug manufacturer if the drug is intended to treat a disease or condition affecting fewer than 200,000 patients in the U.S., or less commonly, if the manufacturer cannot expect to recover the costs of developing and marketing a drug. In some cases, even if the drug developer meets the orphan drug criterion of having no hope of recovering the costs, the drug does actually become profitable—some significantly so—but competitors are still barred from entering the market with a lower-cost alternative during the 7-year exclusivity period that exists by operation of law. To combat this issue, the recently introduced Senate bill (as well as a nearly-identical House bill introduced in October 2019) targets a loophole that allows market exclusivity under the Orphan Drug Act to be extended for future versions of the same drug without the drug's manufacturer having to show that the drug remains unprofitable.
Read more
FDA User Fees: Highlights from FDARA & Our Forecast for the Next Round
February 3, 2020 | Blog
As discussed in an earlier blog post, the process for reauthorizing human medical product user fee programs at the Food and Drug Administration (FDA) for another 5-year period is getting started this year. Below we highlight some changes made to the programs when they were last reauthorized through the 2017 Food and Drug Administration Reauthorization Act (FDARA) (P.L. 115-52) and consider what could be included in the upcoming user fee reauthorization package.
Read more
FDA User Fees: How Do They Work?
January 28, 2020 | Blog
A history of FDA human medical product user fee programs, including those for prescription drugs (PDUFA), generic drugs (GDUFA), biosimilars (BsUFA), and medical devices (MDUFA), their negotiation and reauthorization, and how manufacturers and patients can participate and get involved in the negotiations.
Read more
Health Care: A Clearer Vision in 2020? Don’t Bet On It
January 15, 2020 | Blog | By Tara E. Dwyer
As we noted in our previous blog post, there are several legislative priorities in the health care space that could see action this year. There are also a variety of activities beginning this year that could set the stage for later action. Here’s what we’re tracking for a 2020 health care legislative package.
Read more
Health Care Provisions in 2020 Spending Package
January 9, 2020 | Blog
On December 20, 2019, the President signed into law a bill to fund the federal government through September 30, 2020. The bill included several important health care provisions but left some longstanding policy challenges unresolved. Most notable changes to law are the elimination of three Affordable Care Act taxes and the passage of the CREATES Act. Noticeably absent is legislation related to surprise billing and prescription drug pricing. A summary of key health care provisions included in the 2020 Consolidated Appropriations Act (P.L. 116-94) follows. We will address the legislative outlook for 2020 in a separate ML Strategies blog post next week.
Read more
Health Care Forecast - Massachusetts Legislature
November 12, 2019 | Blog | By Caitlin Beresin, Kaitlyn Sprague, Taylor Shepherd
As the Legislature approaches the Holiday recess, health care costs and access continue to be at the forefront of the agenda. The Baker Administration released the VALUE Act on October 18th and the Senate filed the PACT Act on November 7th.
Read more
ML Strategies Health Care Preview: Surprise Billing Issue Heats Up
September 16, 2019 | Blog | By Alexander Hecht
This week, Congress is working towards passage of a continuing resolution that would fund the government through the middle of November. This will give policymakers and appropriators enough time to hash out differences in funding priorities as well as work on policies addressing drug pricing, surprise billing, and funding for public health programs. The surprise billing issue is really heating up with outside stakeholder groups weighing in and Congress carefully considering its next steps. We cover this and more in this week's preview, which you can find by clicking here.
Read more
Massachusetts Fall Legislative Preview
September 5, 2019 | Blog | By Caitlin Beresin, Daniel Connelly, Steven Baddour, Taylor Shepherd
With less than a year to go until the end of formal sessions on July 31, 2020, Massachusetts legislators are back in action this month to begin tackling a robust policy agenda. We are poised to see action on both new and pending legislation this fall on a number of priority policy areas.
Read more
August Cybersecurity Update: Congress Finishes Up NDAA and Continues Work on Cybersecurity Bills
August 12, 2019 | Blog | By Christian Tamotsu Fjeld, Alexander Hecht
As August recess gets underway for the House and the Senate, ML Strategies has prepared a summary of the status of this summer’s key cybersecurity issues. ML Strategies will continue to track these and other cybersecurity priorities before Congress and the Administration through August and beyond.
Read more
ML Strategies Health Care Preview: August Recess in Sight
July 29, 2019 | Blog
This week, the Senate is expected to vote on a budget deal that would also suspend the debt limit for two years. This clears a major hurdle come September when both chambers of Congress will be in session with a laundry list of policies and programs to address, including appropriations. We cover this and more in this week's preview, which you can find by clicking here.
Read more
Massachusetts Legislature Fiscal Year 2020 Budget
July 24, 2019 | Blog | By Taylor Shepherd, Caitlin Beresin
On Monday, July 22nd the Massachusetts Legislature finalized the Fiscal Year 2020 Budget and delivered it to Governor Baker’s desk for approval. The Legislature’s Budget Conference Committee, led by Chairmen Representative Aaron Michlewitz (D- Boston) and Senator Michael Rodrigues (D- Somerset), authorizes $43.1 billion in state spending for this fiscal year and included the largest annual increase for K-12 education in the state’s history, a $269 million dollar lift.
Read more
Software Update: The Latest on FDA’s Pre-Cert Pilot
July 22, 2019 | Blog
Regular readers of this blog know that we’re closely following the FDA’s proposed regulatory framework for software as a medical device (SaMD), known as precertification—Pre-Cert for short. Generally, Pre-Cert involves a premarket evaluation of a software developer’s culture of quality and organizational excellence and continual, real-time postmarket analyses to assure software meets the statutory standard of reasonable assurance of safety and effectiveness.
Read more
ML Strategies Health Care Preview: House to Vote on Cadillac Tax
July 15, 2019 | Blog
This week, the House is set to vote on repeal of the Cadillac tax, which is a forty-percent tax on high-cost health plans established by the Affordable Care Act. While its prospects for passage in the Senate are not entirely clear, passage out of the House clears an important hurdle. In other news, we are continuing to monitor the evolving drug pricing debate which is still expected to ramp up in the coming weeks with action from the Administration and Senate.
Read more
Explore Other Viewpoints:
- Antitrust
- Appellate
- Arbitration, Mediation & Alternate Dispute Resolution
- Artificial Intelligence
- Awards
- Bankruptcy & Restructuring
- California Land Use
- Class Action
- Complex Commercial Litigation
- Construction
- Consumer Product Safety
- Cross-Border Asset Recovery
- Debt Financing
- Direct Investing (M&A)
- Diversity
- EB-5 Financing
- Education & Nonprofits
- Employment
- Energy & Sustainability
- Environmental Enforcement Defense
- Environmental Law
- FDA Regulatory
- Federal Circuit Appeals
- Financial Institution Litigation
- Government Law
- Growth Equity
- Health Care
- Health Care Compliance, Fraud and Abuse, & Regulatory Counseling
- Health Care Enforcement & Investigations
- Health Care Transactions
- Health Information Privacy & Security
- IP Due Diligence
- IPRs & Other Post Grant Proceedings
- Immigration
- Insolvency & Creditor Rights Litigation
- Institutional Investor Class Action Recovery
- Insurance & Financial Services
- Insurance Consulting & Risk Management
- Insurance and Reinsurance Problem-Solving & Dispute Resolution
- Intellectual Property
- Investment Funds
- Israel
- Licensing & Technology Transactions
- Life Sciences
- Litigation & Investigations
- M&A Litigation
- ML Strategies
- Medicare, Medicaid and Commercial Coverage & Reimbursement
- Mergers & Acquisitions
- Patent Litigation
- Patent Prosecution & Strategic Counseling
- Pharmacy Benefits and PBM Contracting
- Portfolio Companies
- Privacy & Cybersecurity
- Private Client
- Private Equity
- Pro Bono
- Products Liability & Complex Tort
- Projects & Infrastructure
- Public Finance
- Real Estate Litigation
- Real Estate Transactions
- Real Estate, Construction & Infrastructure
- Retail & Consumer Products
- Securities & Capital Markets
- Securities Litigation
- Special Purpose Acquisition Company (SPACs)
- Sports & Entertainment
- Strategic IP Monetization & Licensing
- Tax
- Technology
- Technology, Communications & Media
- Technology, Communications & Media Litigation
- Trade Secrets
- Trademark & Copyright
- Trademark Litigation
- Value-Based Care
- Venture Capital & Emerging Companies
- White Collar Defense & Government Investigations
- Women's Health and Technology