Senators Propose Amendments To S. 959

BillAs many of you pointed out to me in private emails last Friday after I had claimed that things had been quiet, there had indeed been some significant activity on S. 959, “Pharmaceutical Quality, Security, and Accountability Act” (PQSA) that occurred last week.  Even though the bill was awaiting action on the Senate floor, the bill managers in the Senate are apparently able to pull it back and amend it, and that’s what they did.  The bill is a combination of the “Pharmaceutical Compounding Quality and Accountability Act” and the “Drug Supply Chain Security Act” and my interest is in the latter so I will limit my analysis to that part of the current bill.

The amendments are fairly light and sprinkled throughout.  Most have little to no affect on the meaning or implementation of the bill–these include reformatting, corrections and minor logical adjustments–but there are a few things that are notable. Continue reading Senators Propose Amendments To S. 959

Still Waiting For The Senate

us-senate-logoA number of RxTrace subscribers asked me to provide an update on the current state of the federal pedigree legislation since things have been so quiet lately.  As you may recall, the U.S. House of Representatives passed their H.R. 1919, “Safeguarding America’s Pharmaceuticals Act” about six weeks ago (see “InBrief: The Pharma Track & Trace Bill Has Passed the U.S. House Of Representatives“).  The Senate Health Education Labor and Pensions Committee sent their S. 959 “Pharmaceutical Compounding Quality and Accountability Act” to the Senate floor two months ago (see. “InBrief: A Track & Trace bill Has Made It To The Senate Floor“).

So currently we are waiting for Continue reading Still Waiting For The Senate

Summer Writing: Steve Jobs, Bill Gates and Me

Portrait of American businessman and engineer Steve Jobs, co-founder of Apple Computer Inc, at the first West Coast Computer Faire, where the Apple II computer was debuted, in Brooks Hall, San Francisco, California, April 16th or 17th, 1977. (Photo by Tom Munnecke/Getty Images)
Three guys born in 1955

In his excellent 2008 book “Outliers:  The Story of Success”, Malcolm Gladwell examined why the year 1955 seemed to spawn so many of the founders of the personal computer industry, including Steve Jobs, Bill Gates and others.  In a nutshell, it is because being born in that year increased the odds that a person would be at a certain point in their lives in the month of January 1975.  That was the month in which a critical event occurred that most people believe was the trigger for the personal computer revolution:  The Continue reading Summer Writing: Steve Jobs, Bill Gates and Me

InBrief: CBO Estimates S. 959 Would Exceed Unfunded Mandate Threshold For Private Entities In At Least One Year

CBO LogoJust as they did just prior to the U.S. House of Representatives vote on H.R. 1919 “Safeguarding America’s Pharmaceuticals Act of 2013” (see “InBrief: CBO Estimates H.R. 1919 Would Exceed Unfunded Mandate Threshold For Private Entities“), the Congressional Budget Office (CBO) just published their estimates of the public and private costs to implement S. 959 “Pharmaceutical Quality, Security, and Accountability Act” relative to the Federal Unfunded Mandates Reform Act (UMRA), paving the way for a vote in the Senate. Continue reading InBrief: CBO Estimates S. 959 Would Exceed Unfunded Mandate Threshold For Private Entities In At Least One Year

Fall Conference Season Preview

ConferenceI am a fan of attending conferences because, in addition to hearing thought-provoking presentations by knowledgeable speakers, you get to connect with the other attendees to learn what they are doing and thinking.  That’s why it is so important to select the right conferences.  Your goal should be to find the conferences that attract the best attendees so that you have the opportunity to make new connections and get updates from your existing ones.  Of course, the speakers Continue reading Fall Conference Season Preview

Will Generic Drug Manufacturers Serialize Their Drugs In Time?

Get Ready
Get Ready

Important Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.The one thing all pharmaceutical manufacturers can count on, regardless of whether or not the U.S. Congress passes a new track and trace regulation in this or future sessions, is that unit-level serialization will be a necessity on drug packages sold into the U.S. market within the next few years.  We have all been paying close attention to the draft legislation that has been moving through the two houses of Congress for several months now, but there is no doubt that unit-level serialization will be required whether something passes at the federal level or not.  The only questions are, exactly which year will it be required and what else will be required?

We know that Continue reading Will Generic Drug Manufacturers Serialize Their Drugs In Time?

Four Years Of RxTrace

Led_Zeppelin_IV_This week marks the four year anniversary of RxTrace.  The first essay, published on July 4, 2009, said it all, “Welcome to rxTrace“.  And almost four years later I found myself yelling at the California Board of Pharmacy with my most recent essay, “Hey California Board of Pharmacy: Your Time Is Running Out!“.  In between there have been 177 other essays of varying topics and varying quality.  Thanks for sticking with me.

Readership has grown significantly over the last 1 1/2 years.  I don’t make readership numbers public because they probably aren’t as big as one might imagine, but the growth has been incredible.  RxTrace readers are people who are looking for information about pharma and medical device regulations and the technology solutions necessary to meet them.  I call it, “a comprehensive exploration of the intersection between the pharmaceutical (and medical devices) supply chains, track & trace technology, standards and regulatory compliance”.  That about sums it up, I think.

Here is a graph of Continue reading Four Years Of RxTrace