Regulatory Roundup - Pharmaceutical Technology

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PharmTech Europe

Regulatory Roundup

Pharmaceutical Technology
Volume 37, Issue 8, pp. 22

Tracking PDUFA
Instead of waiting five years to assess the successes and shortcomings of the current Prescription Drug User Fee Act (PDUFA), now in its fifth iteration, manufacturers have set up an online system to track actions and results in near-real time. The Industry PDUFA Tracking Database, established by the Biotechnology Industry Organization (BIO) and the Pharmaceutical Research and Manufacturers of America (PhRMA), will collect data from companies on the progress of new applications for drugs and biologics through the review process. Individual companies will have access to data on their own submissions, as well as aggregated, de-identified industry data down to each FDA review division. The aim is for sponsors to enter information in real-time on review outcomes, number of review cycles, timing of meetings and communications with FDA, review letters, and timing of REMS discussions. If the database reveals clear problems with the review process, the information could support changes sooner than the next round of user fee negotiations in 2017.

Challenging India patent grab
Recent actions undermining patent protections for prescription medicines in India has produced a strong reaction from US pharmaceutical companies and support from IT firms and manufacturers in numerous sectors. An industry coalition is pressing the Obama administration to raise concerns about India's unfair trade practices in bilateral and multilateral trade talks and all diplomatic and trade discussions. These issues were discussed at a June hearing before a House Energy and Commerce subcommittee, where Roy Waldron of Pfizer described how India has revoked patents and issued compulsory licenses for a number of leading drugs, most notably Novartis' anticancer therapy Gleevec. Although the Indian government claims its actions are necessary to provide affordable crucial medicines to its population, manufacturers counter that most people in India cannot afford even low-cost generics, and that the government primarily seeks to bolster Indian manufacturers. A greater fear is that India's anti-IP moves will spillover to Brazil, South Africa, Turkey, and other newly industrial countries. Meanwhile, India is moving ahead by authorizing an inter-ministerial panel to set reference prices based on drug rates in Europe, Canada, and other countries.

1. NCPA, "New Report Card on Medication Use Gives Americans a C+," Press Release (June 25, 2013),
2. CVS Caremark, State Adherence Data,
3. IMS Health, Press Release (June 19, 2013),
4. FDA, "FDA Takes Action to Protect Consumers from Dangerous Medicines Sold by Illegal Online Pharmacies," (June 27, 2013).
5. NIH, "NIH to Fund Collaborations with Industry to Identify New Uses for Existing Compounds,",


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