Regulatory Matters: Why the FDA cares about your spam emails

Does anyone read the emails in their spam folder? If you did, you would most certainly find emails from online pharmacies based abroad advertising Cialis, Viagra, and other well-known pharmaceutical brands, available sometimes without a prescription. These medicines are often counterfeit, stolen, or expired and represent a major threat to global health. Activities from counterfeit medications are estimated to cause thousands of deaths globally and generate between $75-100 billion annually (representing about 10% of global pharmaceutical revenue!) There are many reasons why adulterated drugs are so prevalent, but the main reason is perceived cost savings by the consumer.

As I spoke about in my last blog entry, securing the pharmaceutical supply chain has become a major focus of the US FDA. With the passage in late 2013 of the Drug Quality and Security Act (specifically Title II, entitled Drug Supply Chain Security Act), the US Congress has outlined the plan over the next 10 years to develop and build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.” These “track and trace” laws, as they are commonly known, are part of an ongoing effort over the past 30 years to establish a federal track and trace system.
This law in particular will allow the FDA:

· to enable verification of the legitimacy of the drug product identifier down to the package level

· enhance detection and notification of illegitimate products in the drug supply chain

· facilitate more efficient recalls of drug products (1).

Along with other laws, such as FDA Safety and Innovation Act (FDASIA), the FDA has been granted broad powers to investigate instances of counterfeit and illegally diverted medication, conduct seizures, and levy fines. In a recent demonstration of enforcement this past May, the FDA worked in conjunction with Interpol and law enforcement, regulatory agencies and postal authorities from 111 countries to seize over 19,000 packages containing illegal prescription drugs obtained through online pharmacies, in Operation Pangaea VII (2). This was followed in June by the FDA’s shutdown of nearly 1700 online pharmacies and the arrest of 58 people and seizure of $41 million of counterfeit medications (3). While certainly a blow to online pharmacies, these operations highlight the severity of the problem.

Certainly, this isn’t the first attempt to establish an electronic track and trace system. A 2006 compliance document on the Prescription Drug Marketing Act of 1987 defined the concept of an ePedigree document to accompany a drug which incorporates manufacturing and distribution information and is amended by each touchpoint along the supply chain. In 2007,
EPCglobal, a global standards organization, ratified an XML standard (EPCIS) to enable electronic transmission and appending of drug information, as well as allowing for serialization. However, most states which currently mandate Pedigree information allow for a variety of formats, such as text files, spreadsheets, and PDF.
California has adopted the EPCglobal XML standards which will be phased in starting January 2015. Given the size of the California market, this will likely be the de facto national standard until the FDA releases its own standard in the coming years (4).

So what does this mean for pharmaceutical manufacturers and distributors? The implications are wide and far reaching, especially with billions of dollars at stake, and will require these companies to evaluate their IT infrastructure needs within their lines of business,
particularly finance, quality, manufacturing, and distribution, as well as among their suppliers and vendors.

By November 27th of this year, the FDA aims to publish draft guidance on establishing standards for interoperable exchange of transaction information,
history, and statements in paper or electronic format
.
Whether this information will be stored within RFID, barcodes, or some other system is unclear. However, OpenText, with its ECM (documentation) and Information Exchange (EDI) solutions,
is well suited to handle these types of information, regardless of whatever the standard ultimately turns out to be.

To begin the conversation on how OpenText can help, please feel free to contact me at jshujath (@) opentext.com and don’t forget to empty out your spam folder once in a while…

1 Source: FDA.gov

2 Source: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm398499.htm

3 Source: http://usatoday30.usatoday.com/money/industries/health/drugs/story/2011-10-09/cnbc-drugs/50690880/1

4 Source: http://www.pharmacy.ca.gov/laws_regs/e_pedigree_laws_summary.pdf

About Jaleel Shujath

Jaleel Shujath
Jaleel is an Industry Strategist in Life Sciences for OpenText, based near Washington DC.

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