Inside the Beltway this week, as with much of the country, there was a tremendous thaw and we saw temperatures in the 70s. I saw my first daffodils sticking their little green necks above ground. But Washington is fickle. When I moved to this area, it was April 1 and the temperature was in the 70s. On April 2 it fell to the 50s. On April 3 I awoke to snow…..
And here is a little of what changed in our week this week:
- Cross Purposes in FDA Funding – As Republicans in the House of Representatives sought to trip $220 million from FDA’s budget for this fiscal year, the President’s budget for next fiscal year seeks to increase FDA’s budget by 33%. Someone is not listening to someone else.
- President’s Budget Sets New Goal Post for Biosimilars - There is no outward sign of progress on the part of FDA in developing a regulatory pathway for biosimilars, but the President likely took industry by surprise this week when he proposed that the period of exclusivity for branded biologics be reduced from 12 years to 7 years, in an effort to speed biosimilars to market and presumably embrace cost savings as a result. Given that there has been a drastic change in the fiscal climate, this is one of many examples of a concept that may not have held much appeal a year ago, gaining currency today.
- A Pharmaceutical Company Conducts a Twitter Chat – As FDA continues to miss its deadline for some guidance on social media, as pointed out by the TWANK report earlier in the week, industry cannot and is not waiting for an agency that can’t keep up with change. Not long ago, most pharma companies were nearly uniformly too spooked to participate in social media platforms but today there are over 115 pharma sponsored twitter feeds and this week one company used one of their twitter feeds – @AstraZenecaUS – to sponsor a first-ever pharma Twitter Chat under a hashtag #rxsave to discuss ways that patients can save money on prescription drugs.
- FDA Finalizes Medical Devices Regulation Software – FDA announced a final rule that provides a less-burdensome path to market for certain hardware and software products used with medical devices. The rule classifies these products, known as Medical Device Data Systems or MDDS, as Class I or low-risk devices, making them exempt from premarket review but still subject to quality standards.
That’s it for me this week folks. Friday is here about 5 days too late in my opinion. Have a good weekend everyone.