Archives: Pharmaceuticals and PBMs

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2017 NDAA brings privatization and cost-savings incentives to TRICARE

The 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 … Continue Reading

Slow repeal of the ACA and its effect on the pharmaceutical industry

This 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, … Continue Reading

St. Clair v. CVS Pharmacy, Inc. and healthcare calls under the TCPA’s emergency purpose exception

A 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. … Continue Reading

Revised Cuba rules allow medical collaboration, ease some pharmaceutical trade

The 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  … Continue Reading

Recent Regulatory Updates Aimed at Pharmacy (and Retail) Compliance with RCRA

An aisle in a pharmacy. The commercial product(s) or designs displayed in this image represent simulations of a real product, and are changed or altered enough so that they are free of any copyright infringements. Our team of retouching and design specialists custom designed these elements for each photo shoot 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 … Continue Reading

Calls and text messages from healthcare organizations: New developments under the TCPA’s ’emergency purpose’ exception

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 … Continue Reading

Court strips importation and sale of ‘gray market’ glucose test strips in U.S.

Abbott 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 … Continue Reading

EPA proposes new rule for hazardous waste pharmaceuticals

On 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 … Continue Reading

FDA guidance may improve pediatric orphan drug success

The 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 … Continue Reading

FDA Complete Response Letters: The design v. reality of FDA’s responses to drug applications

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 … Continue Reading

Patent issues will remain after FDA approval of Sandoz’ application for filgrastim

The U.S. Food and Drug Administration (“FDA”) panel’s unanimous recommendation to approve Sandoz’ application for a filgrastim biosimilar of Amgen’s Neupogen® on Jan. 7, 2015, brings into sharp focus the provisions of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) for resolving patent issues. The imminent approval by the FDA of Sandoz’ application … Continue Reading

Cutting dietary supplement red tape

Dietary supplements represent a huge sector of the consumer market and changes in both intellectual property law and the regulations governing the market entry and advertising of these products is changing. The new America Invents Act allows anyone to challenge the validity of patents under the inter partes review (IPR) process. In a Sept. 9 … Continue Reading

Husch Blackwell leads the charge in first inter partes review wins against pharmaceutical-related patents

The Patent Trial and Appeal Board (PTAB) issued its first final written decisions June 20, 2014, in four inter partes reviews (IPR) of pharmaceutical-related patents. The four decisions effectively invalidated all 58 of the challenged patent claims spread across four patents owned by Merck & Cie and South Alabama Medical Science Foundation (SAMSF) who previously … Continue Reading

The business case for inter partes review of patents by generic pharma

Several parts of the America Invents Act (the “AIA”) became law on Sept. 16, 2012, sparking some of the most meaningful changes to patent law seen in decades. One hot provision in the new law is the ability for one to challenge a patent’s validity in a new inter partes review (“IPR”) process. This legal … Continue Reading

After a slow start, generic pharmaceutical companies now accelerate their use of inter partes review patent challenges

When inter partes review actions first became available in 2012, no generic pharma companies availed themselves to this litigation tool. Not until 2013 did a generic pharma company first seek inter partes review (“IPR”) of a brand drug patent in Apotex Inc. v. Alcon Pharmaceuticals, Ltd., IPR2013-00012 and -00015. In response to Apotex’s petition for … Continue Reading

Don Mizerk Provides Insight on New FDA Request for Comments

Law360 recently quoted Husch Blackwell attorney Don Mizerk in an article about the FDA’s new request for comments.  In the announcement, the FDA established a public docket to receive suggestions for ways to improve the quality of abbreviated new drug applications (ANDAs) and for the FDA to learn about difficulties sponsors are having with ANDA … Continue Reading

CMS Proposes New Regulations Regarding Part D Program

Scrutiny of physician prescribing (particularly pain management) seems likely to increase in 2015 under new CMS regulations that were published on January 10, 2014. The proposed regulation makes policy and technical changes regarding the Medicare prescription drug program (Part D). Among the changes are the granting of explicit authority to deny (under 42 CFR § … Continue Reading

What We Can Learn from Corporate Integrity Agreements

When was the last time you thought about your compliance program? As we know, an effective compliance program is important for healthcare companies. It’s also important to review your compliance program periodically and update it according to the latest guidance. OIG guidance and recent Corporate Integrity Agreements (CIAs) are informative about what the OIG is … Continue Reading

Pfizer Appeal Targets Fraudulent Drug Marketing Claims Brought Under Civil RICO Statute

Pfizer, Inc. recently petitioned the Supreme Court, seeking review of three companion decisions from the First Circuit Court of Appeals.  These decisions found against Pfizer and in favor of multiple third-party payors (TPPs)—the Kaiser Foundation Health Plan, Inc. (an HMO), Aetna, Inc. (a health insurer), and a putative class of employer health plans—on civil Racketeer … Continue Reading

Texas Governor Reigns in HHSC Inspector General

On June 14ththe Governor signed into law SB 1803. It amends Chapter 531 by limiting the Texas Health and Human Services Office of Inspector General’s (HHSC-OIG) ability to implement payment holds, improving providers’ rights to expedited appeals before the State Office of Administrative Hearings, redefining the liability for hearing costs, creating new requirements for HHSC-OIG … Continue Reading

Be Aware of Your DEA X-Number Registration Needs

An X-number, or “DATA-waived,” registration allows providers holding the registration to avoid U.S. Drug Enforcement Agency (DEA) registration requirements for narcotic treatment programs.  A health care provider that possesses an unneeded X-number registration creates unnecessary regulatory burdens for the provider’s practice.  Specifically, the DEA periodically makes unannounced site visits of all x-number registration holders.  Even … Continue Reading

U.S. Supreme Court Addresses "Failure to Warn" Negligence Claims in Rx Warning Labels

New Hampshire law applies a hybrid design-defect standard that imposes liability for harm caused by a drug product if the drug product, in light of the manufacturer’s warning on the label, is unreasonably dangerous. Does such a framework avoid federal preemption issues that have doomed failure to warn negligence claims premised on taking allegedly dangerous … Continue Reading

Potential Legislation Could Change the Way Compound Pharmacies Do Business

In response to the deadly incidents with a compounding pharmacy in Massachusetts that is blamed for a meningitis outbreak that sickened more than 500 people and caused at least 36 deaths, potential federal legislation has been introduced in the U.S. House of Representatives.  Two bills have been introduced in the U.S. House of Representative that … Continue Reading