Pharmaceuticals and PBMs

749231-F-DHB23-060The 2017 National Defense Authorization Act, Pub. L. No. 114-328 (Dec. 23, 2016), introduces major changes to the Defense Department healthcare program known as TRICARE. By this time next year, we’ll see a new program to contain the cost of prescription drugs at retail pharmacies, contractual incentives for improving the quality of healthcare and reducing “per-capita cost,” and the first major step toward privatizing the delivery of healthcare to military members.

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pills-colorful492864587This is the third article in our series on the effect of a “slow repeal” of the ACA. This week’s discussion focuses on the potential impact of a slow repeal of the ACA on the pharmaceutical industry (Pharma).

Unlike many of the players detailed in our prior articles on the slow repeal of the ACA, Pharma has not made a lot of noise regarding a repeal of the ACA. In fact, Pharma and biotech stocks soared—generally 3 percent to 10 percent—on November 8, 2016, largely because the industry had been preparing for a Clinton victory. A recent quote attributed to one Pharma industry official—“I actually think the Republican Party is a far less certain bet for the pharmaceutical industry”—reflects some of the unease surrounding the change in administration, and the likely repeal of the ACA. Continue Reading Slow Repeal of the ACA and Its Effect on the Pharmaceutical Industry

Phone_000011163163SmallA California federal court handed down a decision last Friday that may further influence how healthcare entities should approach the Telephone Consumer Protection Act’s (TCPA) “emergency purpose” exception as applied to calls or texts related to patient health and safety. In St. Clair v. CVS Pharmacy, Inc., No. 16-CV-04911-VC, 2016 WL 7489047, at *1 (N.D. Cal. Dec. 30, 2016), the plaintiff alleged that CVS Pharmacy called him multiple times about his prescriptions after he told a customer representative that he no longer wished to be called. CVS moved to dismiss the lawsuit by claiming that all of the calls at issues fell under the emergency purpose exception contained in the statute, and therefore were not subject to the TCPA. Continue Reading St. Clair v. CVS Pharmacy, Inc. and healthcare calls under the TCPA’s emergency purpose exception

Cuban flag against skyThe U.S. Department of Treasury’s Office of Foreign Assets Control (OFAC) and the U.S. Department of Commerce’s Bureau of Industry and Security (BIS) recently announced additional rule amendments intended to continue improving relations between the U.S. and Cuba by allowing even greater commerce and humanitarian efforts between the two countries. These new OFAC  and BIS  rules took effect last week. Continue Reading Revised Cuba rules allow medical collaboration, ease some pharmaceutical trade

On September 12, 2016, the EPA issued its Strategy for Addressing the Retail Sector under RCRA’s Regulatory Framework (Strategy Document), which addresses growing concerns about the application of federal hazardous waste regulations to pharmacies and retail operations. The Strategy Document takes into account practices common to pharmacies (e.g., reverse distribution) that present unique compliance issues which are of significant concern given EPA’s enforcement actions during the past few years over similar practices at retail operations like Whole Foods and Wal-Mart.

Husch Blackwell attorneys, Megan Caldwell, Megan McLean and Jonathan Waldron provide the background, regulatory framework and what the proposed regulations could mean to you in a recent legal alert.

gavel-scales2013%20052[The Telephone Consumer Protection Act (TCPA), which imposes a penalty of $500-$1,500 per violation for pre-recorded or auto-dialed calls to cell phones, contains two statutory exceptions to liability:

  • where the recipient of the call provided his or her prior express consent to be called, or
  • where the call was placed for an “emergency purpose.”

47 U.S.C. § 227 (b)(1). While much attention has been focused on “consent,” the FCC’s definition of “emergency purpose” has remained relatively untested in TCPA litigation.

That landscape may be beginning to change. The federal district court’s recent decision in the putative class action lawsuit Roberts v. Medco Health Solutions, et al., No. 4:15 CV 1368 CDP (E.D. Mo., July 26, 2016) recognized that consistent with the FCC’s promulgated definition, the emergency purpose exception must be interpreted broadly to cover any calls that may affect the health and safety of a consumer. Continue Reading Calls and text messages from healthcare organizations: New developments under the TCPA’s ’emergency purpose’ exception

the hand of the elderly woman keeps the device for measurement oAbbott Labs recently obtained a preliminary injunction prohibiting numerous pharmacies, wholesalers, and other distributors from importing or otherwise using in the U.S. Abbott’s FreeStyle® blood glucose test strips that are intended for sale internationally. Chief Judge Amon of the Eastern District of New York found that Abbott is likely to succeed on the merits of its Lanham Act claim that consumers will likely be confused by the sale of “gray market” FreeStyle test strips in the U.S. Continue Reading Court strips importation and sale of ‘gray market’ glucose test strips in U.S.

Pills bottle-92816346On August 31, 2015, the Environmental Protection Agency (“EPA”) issued its long-awaited Management Standards for Hazardous Waste Pharmaceuticals Proposed Rule, which is designed to prevent facilities from disposing of hazardous waste pharmaceuticals by flushing them down the toilet or drain. The proposal creates a new subpart under the Resource Conservation and Recovery Act’s (“RCRA”) hazardous waste regulations for the regulation of hazardous waste pharmaceuticals generated by “healthcare facilities” and “pharmaceutical reverse distributors.” Continue Reading EPA proposes new rule for hazardous waste pharmaceuticals

patient493915589The Orphan Drug Act aims to incentivize treatment of rare disorders or conditions affecting fewer than 200,000 persons in the United States through: (1) federal funding of grants and contracts to perform clinical trials of orphan products; (2) a tax credit of 50 percent of clinical testing costs; and (3) an exclusive right to market the orphan drug for approved orphan indications for 7 years from the date of marketing approval. While these financial incentives certainly make the business decision to engage in orphan drug development more palatable, the FDA does not approve orphan drugs on a separate pathway, despite the limited understanding of the diseases in question that presents developers of these drugs with problems stemming from small sample size and lack of well-defined efficacy endpoints. Continue Reading FDA guidance may improve pediatric orphan drug success

Recent trends in the U.S. Food and Drug Administration’s (“FDA’s”) utilization of Complete Response Letters (“CRLs”) would indicate there may be a disconnect between the intended use of CRLs and the reality of how they are actually being used by the FDA. Pharmaceutical companies seeking to acquire FDA regulatory approval for their New Drug Applications (“NDAs”) or Abbreviated New Drug Applications (“ANDAs”) will often receive a CRL from the FDA instead of an approval. Continue Reading FDA Complete Response Letters: The design v. reality of FDA’s responses to drug applications