Pharmacy Groups Advise FDA on Maximizing Health Benefits, Cost Savings of Generic Biologic Products



Share |


Alexandria, Va. - May 31, 2012 The American Pharmacists Association (APhA), National Association of Chain Drug Stores (NACDS) and the National Community Pharmacists Association (NCPA) recently weighed in with the Food and Drug Administration (FDA) with recommendations to facilitate the entry of lower-cost products into the biologic and specialty pharmaceutical markets.

The pharmacy organizations have sent a joint letter to FDA as the agency works to finalize draft guidance related to the development of biosimilar products—less-expensive versions of complex biologic medicines that are determined to be highly similar or interchangeable. The FDA is working to implement the Biologics Price Competition and Innovation Act, which was enacted as part of the Affordable Care Act (P.L. 111-138).

"Pharmacists are the most accessible healthcare professionals and recommending generic alternatives is a standard pharmacy practice," the groups said in their letter to FDA. "Allowing pharmacists to perform fully within their scope of practice by permitting automatic substitution of cost-effective biologic and specialty medications increases availability, thereby greatly benefitting the entire health care system and the patients it serves."

The joint letter offered the following recommendations for the FDA to consider:

  • Biosimilar products should maintain the same name as their reference biologic counterparts to help prevent confusion. The use of suffixes should be avoided as well.
  • Pharmacists should be able to automatically substitute biosimilar products for their biologic reference product, assuming the FDA deems interchangeability between products.
  • The FDA should provide further guidance regarding whether biosimilar medicines will be determined to be interchangeable with their reference products, how pharmacists can assess appropriateness of substitution for individual patients, labeling provisions for manufacturers, and prescribing standards for physicians.
  • An interchangeability reference list should be developed by the FDA, something similar to the current Orange Book for generics, to assist health care providers in managing these prescription orders.

"Our organizations recognize the need for education and training of health care providers on biosimilars," APhA, NACDS and NCPA added in their letter. "Our organizations are willing to work with FDA and other stakeholders to help develop and provide education to pharmacists."

The American Pharmacists Association, founded in 1852 as the American Pharmaceutical Association, is a 501 C6 organization, representing more than 62,000 practicing pharmacists, pharmaceutical scientists, student pharmacists, pharmacy technicians and others interested in advancing the profession. APhA, dedicated to helping all pharmacists improve medication use and advance patient care, is the first-established and largest association of pharmacists in the United States.

The National Association of Chain Drug Stores (NACDS) represents traditional drug stores, supermarkets, and mass merchants with pharmacies—from regional chains with four stores to national companies. Chains operate more than 40,000 pharmacies and employ more than 3.5 million employees, including 130,000 pharmacists. They fill over 2.6 billion prescriptions annually, which is more than 72 percent of annual prescriptions in the United States. The total economic impact of all retail stores with pharmacies transcends their $900 billion in annual sales. Every $1 spent in these stores creates a ripple effect of $1.81 in other industries, for a total economic impact of $1.76 trillion, equal to 12 percent of GDP. For more information about NACDS, visit www.NACDS.org.

The National Community Pharmacists Association (NCPA®) represents the interests of America's community pharmacists, including the owners of more than 23,000 independent community pharmacies. Together they represent a $93 billion health care marketplace, dispense nearly 40% of all retail prescriptions, and employ more than 315,000 people, including 62,400 pharmacists. Independent community pharmacists are readily accessible medication experts who can help lower health care spending. They are committed to maximizing the appropriate use of lower-cost generic drugs and reducing the estimated $290 billion that is wasted annually by improper medication use. To learn more go to www.ncpanet.org or read NCPA's blog, The Dose, at http://ncpanet.wordpress.com.

Ask Your Family Pharmacist TM