The FTC Issues Warning Letters to Social Media Influencers During Notice-and-Comment Period for Proposed Endorsement Regulation

Regulations compelling speech sometimes give rise to interesting First Amendment issues. 


                On March 6, the Federal Trade Commission (FTC) announced that it had issued warning letter to social media “influencers” for endorsing products from Teami, without adequately disclosing that they enjoyed a material benefit from the company. The company had claimed various health benefits flowed from the tea.

                Although such endorsements constitute private (WC?) speech, the FTC has claimed to regulate the activity since 1980 under “The Guides Concerning the Use of Endorsements and Testimonials in Advertising.” The “Guides” were first “enacted” in 1980, and amended in 2009.

                Regulations compelling speech sometimes give rise to interesting First Amendment issues. Additionally, Supreme Court cases like Expressions Hair Design v Schneiderman and Reed v Town of Gilbert have sometimes been read as suggesting the Supreme Court might start treating all forms of protected speech the same.

                On February 21 of this year, the agency sought comment on yet further proposed changes to “The Guides.” The notice-and-comment period is to end on April 21, 2020. Would you or your group like help in submitting a comment?

Merger of Pennsylvania Inpatient Hospital Services Providers Faces Antitrust Challenge by Government

                The FTC announced late last month that it and the state of Pennsylvania had objected to the merger of Jefferson Health and The Albert Einstein Healthcare Network on the grounds that if consummated, the deal would reduce competition. The agency said that the merger would leave the combined system controlling 60% of the inpatient general acute care hospital services market in and around North Philadelphia, and at least 45% of that market in and around Montgomery County, according to a complaint the agency planned to file in federal court.

All contents (c) 2020 John J. Otrompke, JD

CMS Warns of Incorrect Billing for Trastuzumab

Also, Long Term Hospital Adjustment to be Implemented this Summer

CMS announced last weekend that government auditors, upon reviewing claims data for Trastuzumab (Herceptin) for the last several years, found “numerous instances” of incorrect billing for multi-use vials in cases in which some of the medication was wasted.

The agency stated, “Multi-use vials are not subject to payment for discarded amounts of drug or biological,” and referred providers to Chapter 17, Section 40 of the Medicare Claims Processing Manual.

The Institute for Clinical and Economic Review announced last July that the breast cancer drug, trastuzumab deruxtecan, may be the subject of an ICER review this year.

CMS also announced that the Long Term Care Hospital (LTCH) Discharge Payment Percentage (DPP) Payment Adjustment will be “implemented” on July 6.

CMS Seeks Comments on How to Improve Rural Maternal Healthcare

The deadline for comments is April 12

On February 12, CMS released a request for information "to learn about opportunities to improve access, quality, and outcomes for women in rural communities before, during and after pregnancy."

Would your agency like to submit a comment?

https://ruralmaternalrfi.org/wp-content/uploads/2020/02/Rural-Maternal-RFI.pdf

Proposed Vertical Merger Guidance Relevant to Drug Companies

Antitrust Thinking May Be of Relevance to Small Pharma and Biosimilar Companies 

Would Your Company Like to Submit a Comment?

A proposed antitrust guidance from the DOJ and the FTC may warrant the scrutiny of drug companies and personalized medicine developers.

The draft guidance, "Draft Vertical Merger Guidelines," released on January 10, contains a passage  that may be of unique importance to medicines companies. The passage describes a scenario is which one company is the "sole supplier" of an active ingredient needed for another company to make a drug (see below). Such a scenario may arise in the context of biosimilar manufacturing, among other examples.

"Example 5: Company A is the sole supplier of an active ingredient (the related product) for a pharmaceutical drug made by Company B (the relevant market). Company C is considering entering the relevant market. If Company B buys Company A, the merged firm may find it profitable to refuse to supply the ingredient to any rivals or potential rivals if doing so would deter Company C from entering, or prevent it from financing entry, by requiring it to start producing both the active ingredient and the drug at the same time (two stage entry). If refusing to supply entrants was profitable for the merged firm, and if the likely result was that competition in the relevant market would be substantially lessened compared to the level that would have obtained absent the merger, the merger potentially raises significant concerns and may warrant scrutiny."  

The draft contains numerous other examples of the government's thinking on federal antitrust law.

Comments on the document must be received by February 11.

My book review was published by the International Journal of Constitutional Law's blog

My book review of "Understanding Unconstitutionality: How a Nation Lost Its Way" by Arthur Peltomaa was published by ICONnect, the blog of the International Journal of Constitutional Law.

Light shed on the dilemmas and injustices of constitutional law by a fascinating discussion of Canadian law.

I hope to return to this fascinating subject soon.

http://www.iconnectblog.com/2019/10/book-review-john-otrompke-on-arthur-peltomaas-understanding-unconstitutionality-how-a-country-lost-its-way

Suggested Citation: John Otrompke, Review of Arthur Peltomaa’s “Understanding Unconstitutionality: How a Country Lost Its Way”, Int’l J. Const. L. Blog, Oct. 13, 2019, at: http://www.iconnectblog.com/2019/10/book-review:-john-otrompke-on-arthur-peltomaa’s-“understanding-unconstitutionality:-how-a-country-lost-its-way”