There is no shortage of supply chain concerns for those in the pharmaceutical industry, so I was interested to see the results of a recent survey which asked respondents to rank those challenges. Regulatory compliance, product security and cost management are the top three supply chain concerns globally, according to the findings of UPS’s annual “Pain in the (Supply) Chain” survey of global healthcare logistics executives. For the first time, however, product security surpassed cost management and became the second most-pressing issue, which goes to show just how rampant the proliferation of counterfeit medicines within the supply chain has become.
Fortunately though, efforts are underway on at least two fronts to help address the challenge of maintaining product security. First, when the U.S. Senate and House of Representatives were deliberating on pharma track-and-trace last spring and summer, it was widely believed that the bill would be a priority action when Congress reconvened after Labor Day. That didn’t happen. Recognizing this, two groups—the Pharmaceutical Distribution Security Alliance (PDSA) and Pew Charitable Trusts (which has an internal group called the Prescription Project)—sent a joint letter to the leaders of the relevant House and Senate committees, pushing for action, reports an article on Pharmaceutical Commerce.
According to Washington sources, House and Senate committee staffs have been working on the two versions of the pharma supply-chain bill, the article notes. The most significant difference between the two is that the House bill (which passed the entire House) doesn’t include provisions covering compounding pharmacies, while the Senate version (which passed through a committee) does. Another key difference is that the House bill puts a “ceiling” on what states can require for pharma distribution security, while the Senate version doesn’t—which potentially allows California’s more restrictive track-and-trace system to go into effect. The House bill doesn’t actually require U.S. Food and Drug Administration to establish track-and-trace rules, but as the article explains, it’s hard to imagine all this effort winding up as merely a request for FDA to consider.
Secondly, after considerable delay, an FDA pilot program aimed at easing the importation of active substances and finished medicines in the U.S. has gotten underway. The two-year Secure Supply Chain Pilot Program (SSCPP) is designed to allow the FDA to focus surveillance efforts on high-risk shipments that are most likely to be adulterated or counterfeited, while cutting red tape and delays for low-risk imports, according to an article on Securing Industry.
The initiative recognizes that up to 40 percent of the drugs Americans take are manufactured outside U.S. borders, while up to 80 percent of the active pharmaceutical ingredients (APIs) in those drugs come from foreign sources. The reality is that the FDA will never have the capacity to screen all imported shipments.
There are several aspects of the pilot that are interesting, including that it includes a qualification component that will allow 100 pre-approved applicants to have up to five of their products cleared for expedited import review. Companies who apply to take part must be the sponsor holding the approval for the imported API or finished drug—or the designated overseas manufacturer—and must have shown to be compliant with Good Manufacturing Practice. Applicants will also demonstrate a commitment to securing their drug supply chains as participants in the Customs-Trade Partnership Against Terrorism (C-TPAT), according to the FDA, which has started accepting applications, Securing Industry reports.
Whether the bills actually ever get to the floor of Congress is anyone’s guess, as is what would happen once discussion started. Secondly, it seems to this observer that what FDA really needs is more “teeth” to go after those responsible for counterfeit drugs. Nevertheless, more surveillance is of course also needed and perhaps this new initiative will provide those much-needed capabilities.
What do you think? What’s really needed to minimize the flow of counterfeit or adulterated pharmaceuticals?