Importation of Lactose Free Long Acting Beta-2 Agonist Inhalers

1. Importation of Lactose Free Long Acting Beta-2 Agonist Inhalers Lynda Mitchell, M.A. Parents of Food Allergic Kids (POFAK) LMITCHELL@kidswithfoodallergies.org

2. Current Situation • Cow’s milk allergy affects over 4.6 million in the U.S. • Asthma affects over 20 million in the U.S. • NAEPP guidelines for certain classifications of asthma recommend the use of long acting beta-2 agonist inhalers for optimal management

3. Current Situation • Lactose-free long acting beta 2 agonist inhalers are no longer available in the U.S.; they have been replaced with CFC-free diskus inhalers that contain lactose and trace milk protein that some severely milk allergic asthmatics cannot use • The same manufacturers still produce the lactose free inhalers versions of these inhalers for the Canadian market

4. Current Alternatives • Receive sub-optimal asthma treatment that is not in conformance with NAEPP best practice recommendations • Purchase lactose free inhalers illegally and out of pocket from Canada that are the same as the ones previously available in the U.S.

5. Solution • In situations such as this, where a drug previously FDA approved as safe and effective is no longer available in the U.S. but is available in Canada, importation should be legal, allowable and reimbursable just as when that drug was available in the U.S. market.

6. References 1 Besler, M., Eignenmann, P. &Schwartz, R. (2002). Allergen Data Collection - Update: Cow's Milk  (Bos domesticus). Internet Symposium on Food Allergens. Retrieved on March 24, 2004 from http://www.food-allergens.de/symposium-4-1/cows-milk/cows-milk-abstract.html 2 Nowak-Wegrzyn, A. (2003, June). Future Approaches to Food Allergy. Pediatrics. Retrieved on March 24, 2004 from http://pediatrics.aappublications.org/cgi/content/full/111/6/S2/1672 3 National Center for Health Statistics, Centers for Disease Control and Prevention. Asthma Prevalence, Health Care Use, and Mortality, 2000-2001. 4 National Asthma Education and Prevention Program. (NAEPP)(2002). Quick reference NAEPP expert panel report for the diagnosis and management of asthma – update on selected topics for 2002. Retrieved on March 24, 2004 from http://www.nhlbi.nih.gov/guidelines/asthma/execsumm.pdf 5 Center for Drug Evaluation and Research, U.S. Food and Drug Administration. (2001). Metered-Dose Inhaler Medication: Frequently asked questions. Retrieved on March 24, 2004 from http://www.fda.gov/cder/mdi/mdifaqs.htm 6 Glaxo Smith Kline, Inc. (2003). [Product inserts] Retrieved March 23, 2004 from http://us.gsk.com/products/assets/us_advair.pdf, and http://us.gsk.com/products/assets/us_serevent_diskus.pdf 7 Fiocchi A, Restani P, Leo G, Martelli A, Bouygue GR, Terracciano L, Ballabio C, & Valsasina R. (2003, August). Clinical tolerance to lactose in children with cow's milk allergy. Pediatrics. Retrieved on March 23, 2003 from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12897287 8 Nowak-Wegrzyn, A., Shapiro, G.G., Beyer, K., Bardina, L., & Sampson, H.A. (2004, March). Contamination of dry powder inhalers for asthma with milk proteins containing lactose. Journal of Allergy and Clinical Immunology. [Letter to the Editor] Retrieved on March 23, 2004 from http://www2.us.elsevierhealth.com/scripts/om.dll/serve?action=searchDB&searchDBfor=art&artType=letter&id=as0091674903026770 9 Nowak-Wegrzyn, A., Shapiro, G.G., Beyer, K., Bardina, L., & Sampson, H.A. (2004, March). Contamination of dry powder inhalers for asthma with milk proteins containing lactose. Journal of Allergy and Clinical Immunology. [Letter to the Editor] Retrieved on March 23, 2004 from http://www2.us.elsevierhealth.com/scripts/om.dll/serve?action=searchDB&searchDBfor=art&artType=letter&id=as0091674903026770