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Health Law & Policy Matters

Health Care Attorneys | Mintz Levin Law Firm

FDA’s New Four-Letter Guidance on Biosimilars

Posted in Food and Drug Administration (FDA), Health Care Reform, Payors & PBMs, Pharma & Medical Devices, Pharmacies, Physicians

After months of pressure from industry, health practitioners and even congressional stakeholders, FDA has finally proposed a convention for assigning nonproprietary names (also known as proper names) to biological products. The Agency published notice of its draft guidance on August 28th in the Federal Register, along with a proposed rule to assign new proper names to some already approved biologic products, including the only biosimilar product licensed so far under the abbreviated 351(k) pathway.

The industry has been waiting for some time for FDA’s policy position on nonproprietary naming of biological products, particularly for biosimilars and interchangeable biosimilars. With its position only partially decided in the draft policy, as described further below, the wait will go on while industry players continue advocating their positions to the Agency during the comment period.

So, what has FDA proposed?

In order to avoid inaccurate perceptions regarding the safety or effectiveness of biological products based on their licensure pathway – whether an original biologics application or an abbreviated biosimilar application – FDA has determined that the naming convention will apply to all biological products both prospectively and retrospectively. Per the draft guidance, all biological product nonproprietary names would consist of a core name and a designated four-letter suffix.  This convention will permit products with the same core name to be grouped together in electronic databases and systems, a benefit that would not be possible through use of a prefix. Continue Reading

Back to School – HIPAA 101

Posted in Accountable Care Organizations, Clinical Laboratories, Home Health & Hospice, Hospitals & Health Systems, Long-term Care/Skilled Nursing Facilities, Payors & PBMs, Pharma & Medical Devices, Pharmacies, Physicians, Privacy & Security/HIPAA/HITECH

After a summer that saw major data breaches at the Office of Personnel Management and UCLA Health System, this fall is a great time to take your organization back to school on HIPAA compliance and data security.  Here are four items to add to your fall to-do list, no #2 pencils required. Continue Reading

State Pharmaceutical Pricing Disclosure Laws: Old Story, New Refrain

Posted in Fraud & Abuse, Pharma & Medical Devices, Pharmacies, Reimbursement, State & Federal Audits, Investigations & Litigation

As a veteran of the AWP litigation era, I am struck by the recent state efforts to legislate transparency into pharmaceutical pricing.  Multiple states have introduced bills that would require pharmaceutical manufacturers to produce information to justify the sales price for their drugs.  But the idea that pharmaceutical manufacturers are unilaterally responsible for the costs borne by citizens of these states ignores the tangled web of policies and processes that makes up drug pricing and reimbursement in the United States. State legislators may want to examine the relatively recent history of state Average Wholesale Price (AWP) litigation, and each of their state’s response to the pricing transparency mandates incorporated into the early AWP case settlements, before moving forward to mandate transparency from just one player in the process. Continue Reading

Off-Label Marketing and the False Claims Act

Posted in Food and Drug Administration (FDA), Fraud & Abuse, Pharma & Medical Devices

In a post published earlier this week this week our colleagues Brian Dunphy and Joanne Hawana examined key issues in the recent Amarin decision from the Southern District Court of the New York. The August 7th ruling provided Amarin Pharma, Inc. with a preliminary injunction that blocks FDA from bringing a misbranding action against the company when making truthful statements to physicians regarding off-label uses of the drug Vascepa® (icosapent ethyl).

In addition to giving rise to potential misbranding charges under the Food, Drug, and Cosmetics Act, off-label marketing can give rise to False Claims Act (FCA) lawsuits and has resulted in many sizeable settlements. The basis for FCA cases involving off-label marketing is not that the marketing or prescribing of drugs paid for by federal health care programs for off-label uses is outright illegal, but rather that misleading marketing causes the prescriber to mistakenly believe that the drug is effective for off-label use and that the FDA has approved it for such off-label use. Off-label marketing causes a “false” claim to be made to the federal government when the physician prescribes a drug based on misleading marketing material, which is then paid for by a federal health care program, and the physician would not have prescribed the drug if he or she had known that the drug was not in fact FDA-approved or clinically proven to be effective for the off-label use. Continue Reading

Privacy & Security Matters: Three Bytes for End of Summer

Posted in Privacy & Security/HIPAA/HITECH

Earlier this week Mintz Levin’s Privacy & Security Matters blog posted some useful “bytes” to consider for the latest installment of the “Privacy Monday” series.

Of particular interest for those following health care privacy and security matters is the recent House Energy & Commerce Committee report revealing data breaches and vulnerabilities involving HHS. The Privacy and Security Matters blog post also provides some very practical privacy pointers and most importantly, an invite to our webinar discussion of vendor risk management and data protection on August 26 at 1PM ET.

Click here to get these handy end-of-summer bytes.

Personalized Medicine and Alternative Payment Models

Posted in Accountable Care Organizations, Clinical Laboratories, Health Care Reform, Payors & PBMs, Pharma & Medical Devices, Reimbursement

Earlier this month, my colleague Andy Shin at ML Strategies co-authored an article in the American Journal of Managed Care for a special issue of Evidence–Based Oncology, focusing on personalized medicine.

The article, Alternative Payment Models: Paving the Way of Building a Wall for Personalized Medicine?, highlighted a recent white paper published by the Personalized Medicine Coalition entitled Paying for Personalized Medicine. The authors also discuss how the industry is moving toward value-based payment through alternative payment models (APMs) and how APMs could, if implemented correctly, enhance the main goals of personalized medicine: improving care coordination and managing costs. On the other hand, without appropriate safeguards to ensure high-quality health care services, APMs could limit access to the many advances made in personalized medicine.

The article highlights the three most prominent APMs: Continue Reading

First Amendment Protects Truthful Off-Label Speech by Drug Manufacturers

Posted in Food and Drug Administration (FDA), Pharma & Medical Devices, Physicians

First AmendmentPharmaceutical manufacturers have likely taken note of Amarin Pharma Inc.’s recent success in a pre-enforcement legal challenge against the Food and Drug Administration (FDA or the Agency). On August 7, 2015, Amarin obtained a preliminary injunction that prevents the Agency from bringing misbranding charges against the company for making truthful statements to doctors about off-label (unapproved) uses of the drug Vascepa® (icosapent ethyl). Amarin claimed that FDA’s threat of initiating a misbranding action had a chilling effect on the company’s ability to engage in constitutionally protected truthful speech, and from providing valuable information to physicians. This significant ruling from Judge Paul Engelmayer in the Southern District of New York represents the first time FDA has been enjoined on First Amendment grounds from prosecuting a drug manufacturer for misbranding based on the manufacturer’s truthful marketing of its product.

In filing its complaint against FDA, Amarin sought protection for its speech “both at a general and a statement-specific level.” At a general level, Amarin’s First Amendment challenge alleges that FDA’s threat of misbranding under provisions of the Federal Food, Drug and Cosmetic Act (FFDCA or the Act), 21 U.S.C., §§ 331(a) and 333(a)(1), restricted Amarin’s speech. Based on United States v. Caronia – a 2012 decision from the Second Circuit, discussed previously on our blog, here and here, in which the conviction of a drug company sales representative was vacated because Caronia could not be convicted for on the basis of his truthful speech about off-label uses for a drug – the court broadly held that Amarin may engage in truthful and non-misleading speech promoting an off-label use of Vascepa, and that this speech may not form that basis of a prosecution for criminal misbranding. At the statement-specific level, the court also reviewed in great detail specific statements and disclosures for which Amarin sought comfort would not be the subject of a misbranding action.

Continue Reading

This Week’s ML Strategies Health Care Update: Big Changes (Possibly) Ahead for Drug Manufacturers

Posted in Food and Drug Administration (FDA), Health Care Reform, Pharma & Medical Devices, Uncategorized

On Monday, ML Strategies (MLS) posted its weekly Health Care Update, which provides information from the previous week on a variety of important health care-related topics like implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and state and federal health regulatory developments.

In this week’s Update, MLS highlights two major developments for prescription drug manufacturers (among other topics):

  1.  the Medicaid Outpatient Drug Rule went to the White House’s Office of Management and Budget for final review; and
  2.  a federal district court judge ruled in Amarin Pharma, Inc. v. FDA that a drug manufacturer could market to health care professionals off-label uses for a prescription drug provided the manufacturer’s statements were truthful and non-misleading.

The Medicaid Outpatient Drug Rule could set standards for the Medicaid Drug Rebate Program and also provides for significant changes to what is and is not included in the Average Manufacturer Price (AMP) calculation, as well as how “best price” would be calculated for rebates.  Modifying the AMP calculation for the Medicaid program appears to be a priority for Congress, as the House also expressed interest in this issue when it passed the 21st Century Cures Act.

The Amarin Pharma decision is another significant victory for the drug industry (following the 2012 United States v. Caronia decision that drug manufacturers should be allowed to share and discuss with providers materials that support off-label claims).  Industry stakeholders must now wait to see how the FDA will react to Amarin Pharma and whether it will apply the decision in its off-label oversight framework.

To access past MLS Health Care Updates click here.

FDA Cites Drug Company for Kim Kardashian Endorsement

Posted in Food and Drug Administration (FDA)

This week might have been the first time that an FDA regulatory issue hit the headlines on TMZ and other “celebrity watcher” websites.  In an August 7 Warning Letter sent to the drug company Duchesnay, Inc., FDA complains that a recent social media post by reality TV star Kim Kardashian touting the benefits of the morning sickness pill Diclegis (doxylamine succinate and pyridoxine hydrochloride) was false and misleading because it did not present any risk information about the drug.  FDA also noted that the post failed to include material information about significant limitations of use for Diclegis, including the fact that it has not been studied in women with hyperemesis gravidarum, a rare but serious pregnancy side effect that causes extreme morning sickness.  There are also several warnings and precautions in the approved labeling for Diclegis that were not communicated alongside Kardashian’s glowing review of the product’s effectiveness.  Finally, according to the FDA, these issues with the drug promotion render the product misbranded under the Federal Food, Drug, and Cosmetic Act. Continue Reading

Court Enforces Arbitration Agreement and Requires Employees to Arbitrate FCA Claims

Posted in Fraud & Abuse, Hospitals & Health Systems, State & Federal Audits, Investigations & Litigation

On Mintz Levin’s Employment Matters blog, my colleague David Barmak recently discussed in a blog post a notable case in which a federal court compelled the arbitration of three nurses’ False Claims Act (FCA) retaliation claims against the hospital that employed them.  As described in the blog post, the court went a step further by also requiring the nurses to arbitrate their underlying qui tam FCA claim that the hospital had defrauded Medicare, providing an important precedent for healthcare companies, government contractors, and other employers who do business with the federal government and can be targets of FCA claims.

Arbitration won’t necessarily resolve the qui tam claims. Since the government has a stake in the outcome and is not bound by the arbitration agreement between the hospital and the nurses, the court ruled that, after the arbitration award, the parties must either request that the government consent to the arbitrator’s award or resume litigation of the qui tam claims.

As the blog post points out, this case is another reminder of the important role that arbitration agreements and policies can play as part of a broader dispute resolution strategy for employee claims. The case also underscores the importance of a thoroughly considered and well-drafted arbitration agreement or policy. This is especially so for companies who deal with the federal government and have an opportunity to force employees who become relators and bring qui tam FCA claims to arbitrate those claims.