Cost to develop one new drug

January 13, 2020, 7:00 am

Federal Trade Commission Building in Washington, DC. Image courtesy of Adobe Stock.

How much does it cost for a pharmaceutical company to get one new drug onto the market? As with all variations of “what does it cost” questions the answer is complicated. Any such answer requires explanation of what the calculation means.

Other posts discussing this issue:

According to a 2016 study by Tufts Center for the Study of Drug Development, here is their calculation of what it takes to get one compound to the point of where it is approved for sale:

  • $1.395 billion – out-of-pocket costs – actual cash expended at the point approval is obtained to sell the compound
  • +$1.163 billion – “time costs”, in other words the capitalization of having to invest more than a billion dollars over many years – this represents the opportunity cost of having otherwise been able to invest that money in something else that would have produced a return earlier
  • =$2.558 billion – total capitalized cost at point of receiving approval to sell one compound
  • +0.312 billion – costs incurred for follow-up required by FDA as a condition of obtaining approval – this includes factors such as monitoring long-term side effects, monitoring safety, looking at new formulations or dosage strength
  • =$2.870 billion – total lifecycle costs to develop one new medicine that is approved by the FDA for sale

The study was based on a random selection of 106 drugs from 10 pharmaceutical companies. Since that is a random selection presumably the calculation would apply to all medicines.

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Federal mileage rates for 2020

January 2, 2020, 6:00 am

Image courtesy of Adobe Stock.

On 12/31/19 the IRS published the reference amounts for mileage rates for 2020. Their announcement:

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Update on exposure draft for increased GIK disclosures

December 19, 2019, 11:17 am

Image courtesy of Adobe Stock.

FASB update presentation today (12/19/19) indicated the GIK disclosures project is moving forward as previously outlined.

An exposure draft is expected to be released in January 2020.  There will be a 60 day comment period.

Previous post described the outline and limited scope of the project as approved by FASB:

In condensed form, the project will require separate disclosure of donated goods on the face of the statement of activities and require some additional disclosures in the notes. There will not be any change in valuation of donated medicine.


More articles on GIK valuation. The issue isn’t going away.

November 20, 2019, 10:09 am

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Nicola White, writing at Bloomberg Tax, has several articles following up on the GIK valuation issue after the veto of California AB 1181 by the governor. If you have been following the issue, you will want to check her recent writing.

End of this post discusses the departure from FASB of a project manager long involved with nonprofit rulemaking.

The articles, with a few highlights:

11/4/19 – Bloomberg Tax – Small Fixes Eyed for Charity Accounting as California Backs Off – Article describes why FASB is strongly resistant to any change in GIK valuation.

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FASB provides outline for new disclosures on GIK

November 19, 2019, 7:52 am

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On November 6, 2019, FASB discussed the GIK valuation project.

Back on August 21, 2019, FASB set the scope for the project to include only nonfinancial GIK with measurement (that means valuation) off the table. Staff was directed to work toward an exposure draft (ED) that would address only presentation and disclosure. That means an ED will only describe how GIK is presented on the statement of activity and what information is explained in the notes.

According to minutes of the 11/6/19 meeting, available here, FASB ratified that previous scope.

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How big is the world of donated medicine? Updated estimate.

October 29, 2019, 7:42 am

Medical factory storage warehouse. Image courtesy of Adobe Stock.

This post updates the previous estimate of the volume of donated medicine for the relief & development community of the nonprofit world.

There are a few charities receiving big volumes of medicine donated by the pharmaceutical companies. Those charities then get all those meds distributed to charity clinics and hospitals around the world. That is incredible work which is improving the lives of millions upon millions of poor people around the world.

Following is an estimate of the size of that sector, with subtotal of charities with over $20 million of donated medicine and supplies, under $20 million, and zero reported meds:

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Presentation at CalCPA Accounting and Auditing conference: “California GAAP” – A case study in valuation of donated medicine

October 16, 2019, 11:20 am

Image courtesy of CalCPA.

On October 24 at 3:55 I will be speaking at the California Society of CPAs Accounting and Auditing Conference where industry speakers and experts will provide comprehensive updates on current issues and emerging trends. The conference runs the 24th and 25th.

My topic is valuation of donated medicine in the not-for-profit community. I have the privilege of working with a 75 minute block of time.

If you are able to attend the session you will gain an understanding of the long-term enforcement effort at the federal and state level regarding valuation of donated meds. My concern is that the governor’s veto of AB 1181 is not the end of the enforcement actions considering what has happened over the last 9 years.

Title of the session is “California GAAP” – A case study in valuation of donated medicine.

Overview of the session from the conference schedule:

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