On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
Massachusetts amends anti-kickback law to permit certain prescription drug coupons
The new exception is subject to restrictions. Manufacturers may not exclude or favor any pharmacy in the redemption of the discount, rebate, voucher, or other reduction of out-of-pocket expenses, and manufacturers may not offer such an expense reduction for any prescription drug that has an AB-rated generic equivalent.
The law also permits retail pharmacies to provide discounts or free product vouchers to consumers in connection with a pharmacy service, item, or prescription transfer offer.
These amendments represent a significant change for the manufacturers doing business in Massachusetts. Manufacturers may now provide privately-insured state residents with coupons, co-pay cards, vouchers, and other cost-sharing reductions for their prescription drugs and biologicals so long as the statutory restrictions are followed. Of course, the federal anti-kickback law prohibitions still apply to Massachusetts residents enrolled in Medicare, Medicaid, and other federal health care programs.
For more information, please reference our client alert.
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was...24 January 2017
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017