The Economics of Orphan Drugs: The Effectiveness of Priority Review Vouchers on the Development of Drugs to Combat Neglected Tropical Diseases

Neglected tropical diseases (NTDs) such as malaria and cholera affect more than 1.4 billion people a year. Pharmaceutical companies have historically neglected these diseases, as the affected populations are also some of the world’s poorest. In 2007, a bill was signed into US law that created a Priority Review Voucher (PRV) program. This program grants developers of drugs for neglected diseases a waiver that reduces the time needed for FDA drug approval. This waiver can be sold to other pharmaceutical companies hoping to expedite the process for potential blockbuster drugs. This law is still in its early stages at the time of this paper, and it would not be feasible for any drugs to be fully approved due to the long drug development timeline. By analyzing FDA clinical trial data, though, initial trends can be analyzed for the development of drugs for NTDs. The clinical trial data does not fully support the effectiveness of the PRV program, but recent sales prices support that the market incentives are working correctly

Patch Test Reactions Associated With Topical Medications: A Retrospective Analysis of the North American Contact Dermatitis Group Data (2001-2018)

BACKGROUND/OBJECTIVES: Topical medications may lead to allergic contact dermatitis. This study characterized positive patch test reactions associated with medications in patients evaluated by the North American Contact Dermatitis Group (NACDG). METHODS: This study is a retrospective analysis of the NACDG data (2001-2018). Patients with at least 1 positive patch test reaction associated with a medication source were included. Allergens, reaction characteristics, clinical relevance, and source details were tabulated. RESULTS: Of 43,722 patients, 6374 (14.6%) had positive allergic patch test reactions associated with 1 or more topical medication sources. Patients with versus without allergic reactions to medications were more likely to be older than 40 years (P \u3c 0.0001) and/or have primary sites of dermatitis on the legs, anal/genital region, or trunk (P \u3c 0.0001). There were 8787 reactions to NACDG allergens; the most common were neomycin (29.4%), bacitracin (29.1%), propylene glycol 100% (10.6%), tixocortol-17-pivalate (10.0%), lidocaine (7.9%), budesonide (4.9%), and dibucaine (4.4%). Propylene glycol 100% was the most common inactive ingredient (10.6%). Current relevance was present in 61.0%. A total of 6.5% of the individuals with medication allergy would have had 1 or more positive patch test reactions missed if only tested to the NACDG screening series. CONCLUSIONS: Positive patch test reactions associated with topical medications were common (14.6%), and most were clinically relevant. Patients with topical medication allergy were twice as likely to have anal/genital involvement. Active ingredients, especially neomycin, bacitracin, and tixocortol-17-pivalate, were frequent culprits