The U.S. Supreme Court largely upheld the constitutionality of the healthcare reform law known as the Affordable Care Act, thus allowing the Food and Drug Administration (FDA) to move forward with the implementation of provisions creating an approval pathway for biosimilars, generic drugs that are the equivalent of brand-name biologics.
The Biotechnology Industry Organization (BIO) issued a statement following the ruling, indicating that it would “continue to work with relevant federal and state agencies to ensure implementation of the law in a manner that helps enable the U.S. biotech community’s continued development of lifesaving cures and other medical breakthroughs while expanding patient access to these critical cures, medicines and innovations.” While no manufacturers have yet to submit an application for FDA’s approval, it is apparently anticipated that the first biosimilars will enter the U.S. market in 2014 or 2015.
Meanwhile, medical device manufacturers face a new 2.3 percent excise tax under the law. Scheduled to take effect in 2013, this provision was intended to help pay for health-care reform. The tax will affect medical device products diagnosed for human use, but apparently exempts prescription eyeglasses, contact lenses and hearing aids, in addition to over-the-counter devices. Efforts to repeal the tax have, to date, been unavailing. See BIO News Release and Law360, June 28, 2012; Healthcare IT News, June 29, 2012.