Triple Impact: 3 Regulations that Could Have a Big Bearing on Pharma in 2011

Andrea Charles
Posted: 03/16/2011

Regulatory guidelines are having a huge impact on new pharmaceutical development. With more emphasis on patient safety than ever before, the number of new drugs being approved has been reduced. 

In New Drug Approvals FDA/EMA 2010, Krishan Maggon, Consultant Pharmaceutical Biotechnology R&D & Advisor, said: “The FDA approved 21 new drugs in 2010 compared to 25 in 2009 and 21 NME approved in 2008. The number of new drugs approved has remained in the 20- 25 range by the FDA and EMA each during the past 4 years. The number of new drugs approved by the EMA was only 14 a historic low in recent years.”

"Biologics (monoclonal antibodies, vaccines) accounted for half of the new approvals in 2010. Vaccines and monoclonal antibodies account for a major share of newly approved biologics," said Maggon. 

In Pharma IQ’s recent regulatory forecast discussion, we asked “What regulations will impact the pharmaceutical industry the most in 2011?” Below are just some of the responses:     

1. Truthful Prescription Drug Advertising and Promotion (Bad Ad Program)

“In the US FDA's DDMAC: Truthful Prescription Drug Advertising and Promotion (Bad Ad Program) looks like an "iceberg"...1/4th showing but 3/4th still underwater...will be hard to comply with,” said Jon Nakapalau, CHSO, CPO Physical Security Consultant

2. Expected digital and social media guidelines from FDA

“The FDA will release guidance governing how pharmaceutical companies can use digital and social media to promote FDA-regulated products…There will be growth in the ability of social media to promote pharmaceutical brands, you will see advances in how online digital media push consumers into making product decisions.

The opportunities to disseminate and share information across a global, online enterprise are infinite. It remains to be seen how product marketing will co-exist alongside FDA scrutiny and just how detailed FDA guidelines will be,” said  Katherine Daigle, Senior Director Contract Manager expertise in Contract Compliance, Contract Negotiation and Contract Management.

Sources: (

3. Real-time PSE tracking/reporting

"From an internal perspective if States institute a "Real Time PSE Tracking/Reporting" that will be a nightmare for many customers internal information systems, especially those with legacy systems that are currently using pen and paper still," said William Klusovsky MSIT, CISSP, Information Security Leader.

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Andrea Charles
Posted: 03/16/2011

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