Seeking Supply Chain Security

Pharmaceutical production is a global industry, with increasingly long supply chains and greater reliance on vendors for raw materials and finished products. While these developments may reduce production costs and expand access to important medicines around the world, they also raise the risk of lax quality control and widespread drug diversion and counterfeiting. Drug shortages appear to be one result, raising calls for intense regulatory scrutiny. The proliferation of fake and substandard medicines also points to the need for better control over the pharmaceutical supply chain in the United States and overseas.

Jill Wechsler

Congress addressed some of these problems in the FDA Safety & Innovation Act (FDASIA) of 2012 by requiring manufacturers to notify FDA of pending shortages. It also strengthened the agency's authority to oversee and block substandard imports, to inspect foreign manufacturers, and to levy stiffer penalties for drug counterfeiting. But FDASIA failed to establish a much-debated system for tracking drugs and medical products through the supply chain. That issue is now before Congress, along with proposals to strengthen FDA oversight of large-scale drug compounders. In both cases, the House and Senate are far apart, raising doubts about effective action.

Compounding and tracking

That is somewhat surprising, because there's usually a sharp response on Capitol Hill when contaminated medicines lead to dozens of deaths and widespread illness. The legislators generally agree on the need for clearer standards to prevent broad distribution of illegally compounded injectible drugs, yet pharmacists are leery of greater FDA control over these operations. A bipartisan Senate measure would provide FDA with authority to regulate a new category of commercial compounders—large-scale operators that sell risky injectibles across state lines without prior individual prescriptions. FDA supports this move, as well as provisions that leave "traditional" pharmacy compounders under state law.

However, House Republicans oppose giving FDA more control over compounders, claiming that the agency already has sufficient authority to regulate illegal operators and should do that more effectively. At recent hearings before the House Energy & Commerce Committee, Republicans attacked FDA officials for failing to move aggressively against large compounders that caused hundreds of serious fungal infections. FDA reported on its recent efforts to beef up inspections of "high risk" compounders and close down violative operators. But agency inspectors had to obtain court orders to enter some facilities that tried to block their visits, illustrating the inadequacy of the current law.

The Senate Health, Education, Labor & Pensions (HELP) Committee linked its compounding bill to a measure establishing an electronic tracking system for prescription drugs. The legislation requires lot-level tracking initially, but sets up a 10-year process for adopting a unit-level traceability system, as preferred by FDA. However, legislation approved by the full House in June establishes an "enhanced" drug tracking system—but without a clear path to unit-level reporting.

Both House and Senate track-and-trace bills pre-empt state laws, a move championed by pharma companies anxious to halt adoption of diverse drug tracking programs on the state level. But broad pre-emption has drawn opposition from California members of Congress who oppose any federal drug tracking system that is less stringent than the one set for implementation at home in 2015. Congressional leaders have talked about enacting legislation by August, but agreement may take much longer.

Global challenges

Meanwhile, shortages and security are causing serious health problems around the world. The President's Emergency Plan for AIDS Relief (PEPFAR), which has provided $1.2 billion in antiretroviral drugs to some five million people in Africa and other nations during its first 10 years, is taking steps to ensure the security of its supply chains. An April 2013 report from the Government Accountability Office (GAO) notes the need for better inventory controls and records to avoid shortages, waste and loss of supplies—especially if the program is to expand to serve 23 million eligible people.

Notice to Industry: Own It

Efforts to control and treat tuberculosis have been hampered by shortages of first-line treatment isoniazid (INH) in the United States and abroad. While US public health officials are worried, the situation is more deadly in India and other regions where there's great danger of generating multi-drug resistant TB strains if patients have to stop taking medicines. Manufacturers Sandoz and Teva have moved to ramp up production in response to a temporary shut-down at VersaPharm. But delayed and unclear procurement projections by government health programs, as well as low prices for these widely used drugs, have discouraged additional manufacturers to move into the TB drug market.

A flood of counterfeit and falsified antimalarial drugs in Africa and other developing nations has generated calls from the Obama administration and international organizations for more aggressive strategies to track drug supplies. Many of the bogus products have no active ingredient, while diversion of genuine drugs robs public health programs of vital treatments. These developments raise the specter of generating resistance to effective medicines, which would undermine a decade of progress in reducing malaria-related deaths.

The President's Malaria Initiative is working with local authorities to better protect international and local supply chains, while also encouraging manufacturers to add special markers or tags to packages of artemisinin-based combination therapies, currently the most effective antimalarials. The fight against malaria may be strengthened by progress in development of a synthetic version of artemisinin, with has begun production at a Sanofi plant in Italy. In addition, FDA is testing use of a handheld counterfeit drug detection device, developed by agency scientists to determine quickly if a medical product is real or bogus.

Jill Wechsler is Pharm Exec's Washington correspondent. She can be reached at jwechsler@advanstar.com.