Tag Archives: Counterfeit Drugs

DQSA of 2013

DQSA: Dancing Around The Returns Problem

February 17, 2014 Dirk Rodgers

There is an interesting dialog going on in the Food and Drug Serialization Professionals group in LinkedIn that was kicked off by a recent RxTrace essay. Click here to see the conversation. It got real interesting when Marc Rosenblatt, Director of Sales at Veracity Network, related an experience his company had in a recent pilot. He said:

“…An unsettling example occurred during one of our distributor pilot programs. Our system detected a number of counterfeit products (9% of the total sample to be exact) that were sent back as returns. This means that the molecular structure or product signature didn’t match up with the legitimate product standard. Upon further examination, it was discovered that the sealed bottles contained counterfeit replacements for the valid product. What makes this even a more difficult pill to swallow (pun intended) is the fact that these products would in most cases be restocked and sold again. The returns areas are the most overlooked link in the supply chain and from reading the DSCSA text, it continues to be (at least for the next 4 years).”

Marc’s reading of the Drug Supply Chain Security Act (DSCSA), which is Title II of the Drug Quality and Security Act (DQSA), gives him some comfort Continue reading DQSA: Dancing Around The Returns Problem →

DQSA of 2013

How the DQSA Will–And Won’t–Protect The Supply Chain, Part 1

January 22, 2014 Dirk Rodgers

The supply chain provisions contained within the Drug Quality and Security Act (DQSA)—themselves known as the Drug Supply Chain Security Act (DSCSA)—mark a significant achievement by Congress and the industry to protect the U.S. pharmaceutical supply chain from criminals. It is the first completed attempt since 1987 when the Prescription Drug Marketing Act (PDMA) was enacted by Congress and signed by President Ronald Reagan. In comparison, the provisions of the DSCSA are much more detailed and extensive than the PDMA and they read as if they were heavily influenced by people who solidly understand the scale and complexity of the legitimate supply chain. Which, they were, based on the contribution of the Pharmaceutical Distribution Security Alliance (PDSA)—made up of key stakeholders in the supply chain—in their development. That should ensure that the industry will be able to adopt the technology and process modifications necessary to meet the new law on time.

But will all this also lead to true protection of the supply chain from criminal activities? Will the DSCSA portion of the DQSA end up presenting new and insurmountable barriers against criminals who game the supply chain to their advantage and thereby putting patients at risk? These are the true measures of the success of this type of legislation. How can we know if the DSCSA will have these positive affects? Continue reading How the DQSA Will–And Won’t–Protect The Supply Chain, Part 1 →

exemptions

Drug-Device Combo Products Under State And Federal Pedigree Laws

November 11, 2013 Dirk Rodgers

Metered dose inhaler drug-device combination product

Both the California ePedigree law and the potential federal pedigree law that currently exists within the womb that is H.R. 3204 contain an exemption for drug-device combination products. This is an expanding category of products so this exemption is worthy of a closer look.

The drug-device combo product exemption language included in the California Business and Professions Code, 4034(g)(9), is almost identical to the language in H.R. 3204, 581(24)(B)(xii). There is a reason for that. They are both based on part of the FDA’s definition for a drug-device combination product, found in 21 CFR 3.2 (e). Continue reading Drug-Device Combo Products Under State And Federal Pedigree Laws →

FDA

InBrief: Comments on H.R. 3204 by FDA’s Dr. Ilisa Bernstein at PSM Interchange 13

October 25, 2013 Dirk Rodgers 1 Comment

Dr. Ilisa Bernstein, Pharm.D, JD, Deputy Director of the U.S. FDA Office of Compliance in the Center for Drug Evaluation and Research (CDER), delivered the keynote address at yesterday’s Partnership for Safe Medicines (PSM) Interchange 2013 event (see “Dr Ilisa Bernstein of FDA CDER Office of Compliance To Keynote PSM Interchange”).

Her presentation covered the full range of activities that the FDA is currently pursuing to improve the security of the U.S. pharmaceutical supply chain, including their efforts to implement the new powers they were given by Congress in last year’s FDA Safety and Innovation Act (FDASIA). Continue reading InBrief: Comments on H.R. 3204 by FDA’s Dr. Ilisa Bernstein at PSM Interchange 13 →

Conferences

Fall Conference Season Preview

July 15, 2013 Dirk Rodgers

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 →

Congress, Federal Pedigree

The Federal Lot-Based Pedigree Before Congress

June 3, 2013 Dirk Rodgers 7 Comments

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 →

supply chain security

The Supply Chain Provisions Of The FDA Safety & Innovation Act

February 11, 2013 Dirk Rodgers 1 Comment

Secretary of Health and Human Services Kathleen Sebelius, President Barack Obama, Representative Nancy Pelosi

Last fall the U.S. Congress passed the Food and Drug Administration Safety and Innovation Act, or FDASIA, and the bill was signed into law by President Obama. The purpose of the legislation was primarily to re-authorize user fees that are paid by manufacturers of drugs, medical devices and biologics, but the law also contains quite a few other things. Readers of RxTrace will recall that the well-organized attempt to add a nationwide track & trace requirement to the bill failed (see “PDUFA Will Not Include RxTEC”), but a number of very significant supply chain security elements did make it into the law under the title “Title VII—Drug Supply Chain” (see the full text of the law here). A closer look at these provisions is long overdue. Continue reading The Supply Chain Provisions Of The FDA Safety & Innovation Act →

Counterfeit Drugs

InBrief: Illegally Imported Drugs Found To Be Counterfeit…Again

February 6, 2013 Dirk Rodgers

Yesterday the FDA alerted healthcare providers that a cancer drug illegally imported and distributed to medical practices by a licensed pharmaceutical distributor going by the names “Medical Device King” and “Pharmalogical”, and Taranis Medical, is counterfeit. The FDA alert can be found here. Once again, the drug is labeled as Altuzan, a version of bevacizumab which contains the same active ingredient as Avastin. Here is AP story about it. Here is the WSJ article about it.

Avastin was the subject of a counterfeit importation crime about a year ago, (see “How Counterfeit Avastin Penetrated the U.S. Supply Chain“).

It is illegal to import drugs that are not approved by the FDA for sale and use in the U.S., and so even if the drug had not turned out to be a counterfeit version, this would have still been a crime. It makes me wonder if the reason this case came to light was because the drug name on the package was clearly not approved here. What if the counterfeit drug had been Continue reading InBrief: Illegally Imported Drugs Found To Be Counterfeit…Again →

…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance