I 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
Tag Archives: Congress
Will Generic Drug Manufacturers Serialize Their Drugs In Time?
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?
The California ePedigree Timeline Vs. The Senate Bill Timeline
The U.S. House of Representatives passed their H.R. 1919, Safeguarding America’s Pharmaceuticals Act a few weeks ago (see, “InBrief: The Pharma Track & Trace Bill Has Passed the U.S. House Of Representatives” and also don’t miss “An Industry Protection Bill Concealed Under The Veil Of Patient Protection”). The Senate is next up with S. 957 Drug Supply Chain Security Act (or S. 959 depending on if they really did combine it with the compounding act as they passed it out of committee).
We still don’t know exactly when this bill will be debated or considered in a vote on the Senate floor but indications are that Continue reading The California ePedigree Timeline Vs. The Senate Bill Timeline
Should Pharmacies Decommission EPCs Upon Dispense?
I finally had a chance to listen to the recording of the rfXcel webinar with Virginia Herold, Executive Officer of the California Board of Pharmacy, and Joshua Room, Deputy Attorney General, California Department of Justice assigned to the Board of Pharmacy. The webinar was recorded on May 29, 2013. Ms. Herold and Mr. Room have done these kind of webinars before (see “Q&A With Virginia Herold, Executive Officer, California Board Of Pharmacy”). But don’t worry, while there is a fair amount of repetition as you might expect, the Q&A is different enough that I always learn something new. I found this one to be entertaining as well as informative.
One of the questions they addressed was Continue reading Should Pharmacies Decommission EPCs Upon Dispense?
InBrief: The Pharma Track & Trace Bill Has Passed the U.S. House Of Representatives
Late yesterday The Hill, a political news website, began reporting that the U.S. House of Representatives has passed H.R. 1919, Safeguarding America’s Pharmaceuticals Act in a voice vote that required a two-thirds majority vote. I was watching the House floor streaming feed live as it happened and I must admit that the parliamentary proceedings were slightly confusing to me regarding the vote, so now that The Hill is reporting passage I feel more comfortable saying the same thing. 😉
The text of the bill as it was before the vote appears here.
During the debate leading up to the vote, Continue reading InBrief: The Pharma Track & Trace Bill Has Passed the U.S. House Of Representatives
InBrief: CBO Estimates H.R. 1919 Would Exceed Unfunded Mandate Threshold For Private Entities
Just one business day before the U.S. House of Representatives is scheduled to vote on H.R. 1919, Safeguarding America’s Pharmaceuticals Act of 2013, the Congressional Budget Office (CBO) published their estimates for the public and private costs to implement it relative to the Federal Unfunded Mandates Reform Act (UMRA).
CBO has determined that the costs to State, local, and tribal governments would be “…small and below the intergovernmental threshold established by UMRA…”. However, they also estimate that the costs to private entities “…would exceed the threshold established in UMRA ($150 million in 2013, adjusted annually for inflation)”.
Interestingly, the CBO used Continue reading InBrief: CBO Estimates H.R. 1919 Would Exceed Unfunded Mandate Threshold For Private Entities
The Federal Lot-Based Pedigree Before Congress
The current drafts of the nationwide pharmaceutical track and trace (Pedigree) bills on the floors of the U.S. Senate and House of Representatives both include an initial lot-based pedigree requirement that may be based on paper or electronic documentation (see “The Politics Of Federal Track & Trace Legislation”). What is a lot-based pedigree and how is it different from one based on package-level serial numbers? Let’s take a closer look at the kind of system that these bills would require. Keep in mind that the Senate bill would mandate this kind of pedigree system for the next 10 years and the House bill would make it permanent.
First of all, according to both bills, pharma manufacturers would be required to Continue reading The Federal Lot-Based Pedigree Before Congress
The Politics Of Federal Track & Trace Legislation
Watching the progress of the nationwide pharmaceutical track & trace bills in the U.S. Congress has been very educational. Now that different track & trace bills are on the floors of the Senate and the House of Representatives (see “InBrief: A Track And Trace Bill Has Made It To The House Floor” and “InBrief: A Track & Trace bill Has Made It To The Senate Floor”) I have been trying to pick up on the politics that underlies the current situation in an attempt to figure out what is likely to happen next.
Both of the current bills have been described as “bipartisan”. I don’t think that’s exactly true, but before I explain why, Continue reading The Politics Of Federal Track & Trace Legislation
