Regulatory Roundup - Pharmaceutical Technology

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Regulatory Roundup


Pharmaceutical Technology
Volume 37, Issue 8, pp. 22

Pushing adherence
Appropriate use of medications promises to improve patient care and curb spending, prompting pharmacists, public health authorities, and manufacturers to promote multiple adherence strategies. A report card on medication adherence from the National Community Pharmacists Association gives low marks to consumers in filling and re-filling prescriptions and for mis-using medicines—particularly individuals with chronic conditions (1). Similarly, an analysis by CVS Caremark predicts $6.5 billion in annual savings if patients fill prescriptions 80% of the time (2). More broadly, the IMS Institute for Healthcare Informatics projects $200 million in annual savings by using prescription medicines "more responsibly" (3). That savings includes $35 billion from prescribing antibiotics only when necessary and appropriate, plus $105 billion from proper drug use that avoids hospitalizations, emergency room visits, and other care. Manufacturers are offering new solutions to track and promote appropriate medication use, notably through mobile apps and text messaging to remind patients of refills and timely administration. New pills with digestible microchips and sensors may help providers monitor patients taking their meds.

Safe imports?
A new Maine law permits residents to purchase prescription drugs from mail-order pharmacies in Canada and other countries, a move designed to ease access to low-cost medicines. Employers and state agencies predict savings of more than $10 million a year, and supporters of the program maintain that the imported drugs are just as safe and effective as more costly versions in the US—a position that FDA challenges. In fact, FDA continues to work with INTERPOL, foreign regulatory agencies, and manufacturers to crack down on illegal online pharmacies, many part of organized criminal networks that market fake and sometimes dangerous medicines. In a broad enforcement action in June 2013, FDA and international law enforcement agencies took action against some 9600 illegal websites and seized more than $40 million in illegal medicines (4).

Rescuing abandoned drugs
Undeveloped compounds from Astra Zeneca, Eli Lilly, Johnson & Johnson's Janssen, Pfizer, and Sanofi will be studied by academic researchers under the first round of "repurposing" grants from the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH). NCATS is providing $12.7 million for nine research projects that will seek new therapeutic uses for molecules that have been partly developed by manufacturers, but dropped largely due to poor efficacy or for business reasons. The companies are supplying the compounds, which will be tested collaboratively in preclinical through phase 2 studies (5). Industry has been skeptical that the NCATS repurposing program will bear fruit, but the initiative has strong backing from NIH director Francis Collins as a strategy for accelerating discovery of new therapies for critical diseases.


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