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Pharma Industry News Update: 17 March 2017 Previous Issue


On Thursday, the Trump administration released a preliminary 2018 budget proposal, which has good & bad news for the life sciences industry. The good news - or is it bad? - is that the FDA can collect a lot more user fees from pharma. This may give the agency resources to accelerate the drug approval process. The bad news is a cut in NIH funding leading to less gov't funded biomedical research that the drug industry depends upon.
PDUFA Fees for Rx Drugs Paid by Pharma to FDA Will Skyrocket Under Trump's Proposed Budget

From in.reuters.com


For 2018, the Trump administration has budgeted over $2 billion in fees to be collected by the U.S. Food and Drug Administration from industry, twice as much as in 2017, according to budget documents released on Thursday.

The FDA has been charging companies to review their products since 1992. Most of the user fees collected are for prescription drugs - around $866 million estimated in 2017 - and generic drugs - around $324 million, according to the FDA website. The FDA's 2017 budget was $5.1 billion, the website said.

[The accompanying chart shows fees specifically for Rx drugs. The 2018 is an estimate based on 73% of the total proposed PDUFA fees (as was the case in 2017).]

From the president's budget blueprint: "To complement the increase in medical product user fees, the Budget includes a package of administrative actions designed to achieve regulatory efficiency and speed the development of safe and effective medical products. In a constrained budget environment, industries that benefit from FDA's approval can and should pay for their share."

More here...

Further Reading:


Trump's Budget Would Put NIH & U.S. Medical Research into a Nose Dive!

From www.washingtonpost.com


The National Institutes of Health would absorb an enormous $5.8 billion cut under President Trump's first budget proposal - equal to about 19 percent of its current $30.3 billion discretionary budget.

The plan "includes a major reorganization" of NIH's 27 institutes and centers and would eliminate the Fogarty International Center, a $69.1 million program dedicated to building partnerships between health research institutions in the United States and abroad.

More here...

This is a good reason for friends of the biosciences and drug industry to participate in the April 22 March for Science.


FDA May Establish "Office of Patient Affairs" to Capture Patient Perspectives

From www.raps.org


As part of efforts to better capture patients' perspectives, the US Food and Drug Administration (FDA) on Monday said it is considering establishing an "Office of Patient Affairs," to be tasked with supporting and coordinating patient engagement across the agency.

The office would likely host and maintain data management systems to incorporate and formalize knowledge shared with FDA by patient stakeholders and FDA's relationships with patient communities, and the office would be part of efforts to develop a scalable and forward-looking platform for communicating with patient stakeholders, particularly online.

More here...

Further Reading:


Over Half of the DTC Ad Spend by the Top 10 Advertised Drugs in 2016 was Made by Pfizer

From www.fiercepharma.com


Pfizer led the top branded spending for Lyrica, with $174 million on fibromyalgia ads and another $170 million advertising its indication for diabetes-related pain, for a total of $344 million. Lyrica was trailed by another Pfizer drug, rheumatoid arthritis-fighter Xeljanz, at $189 million.

And Pfizer didn't stop there; five of the top nine meds with the highest spending are Pfizer brands (6 if you count Eliquis, which Pfizer co-marketed with BMS).

More here...

Further Reading:

Pharma Industry News Update
Welcome to Pharma Industry News Update (aka PinUp), which is published every Tuesday and Friday as part of the Pharma Marketing News subscription service. PinUp presents curated content of topical interest from a variety of sources.

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