Legal Research

This Week?s Biotech Highlights

By Jeremy Grushcow

There weren’t exactly an Ark’s worth of devleopments this week, but what did develop came two-by-two.

This week saw two very public regulatory developments in the U.S.:

• The FDA took two heavy steps against highly visible advertising: they said that General Mills’ claims on Cheerios boxes that the cereal can help lower cholesterol means that Cheerios are a drug and should be tested and regulated accordingly; and they chastised a number of pharma companies for ads placed with Google because the ads (limited to 95 characters) do not contain the required risk information. 
• Also in the U.S., Rep. Pallone held hearings at the Subcommitee on Health (of the House Committee on Energy and Commerce) about the Medical Device Safety Act of 2009, as the landscape of state tort liability for regulated drugs and devices has been evolving in the U.S. over the last two years.

There were also two interesting Trends in 2009 updates in the realm of comparative effectiveness:

• In one instance, the FDA decided to approve a new drug without any evidence that it performed better than existing products. 
• On the other hand, a pharma company doing its Phase III trials voluntarily took on a head-to-head comparison with an existing product. 

What does this tell us?  Even if there is no regulatory imperative, a direct comparison is a powerful sales pitch.

Finally, there were two new data points giving us information about the state of Canada’s biotech industry:

• E&Y?s annual biotechnology report was released a week ago, and the reported taglines ranged from ?time of reckoning? to ?biotech business model crumbles?.
• The first report from Canada?s Science, Technology and Innovation Research Council said that Canadian businesses are stingy in funding research and development.

However, the only thing these studies really told us is that the end of 2008 was looking grim.  It’s like checking in with Noah around day 35 of the flood.  2009 is a whole different story, with much to look forward to.  Speaking of which…

Looking forward this week on the Cross-Border Biotech Blog, stay tuned for updates from the BIO 2009 international convention.  It turns out Atlanta is the best place to try to spot a Canadian politician this week:  Tony Clement, Dalton McGuinty and John Wilkinson are all in attendance.

Full post as published by Slaw.ca on May 18, 2009 (boomark / email).