The AHA understands it will take time for new FDA initiatives authorized in legislation enacted last year to show significant effect, but cautions that the shortage situation remains serious. “While the numbers of drugs newly in shortage began to decline in 2012, many of the existing shortages have not been resolved,” AHA notes in a letter to FDA Commissioner Margaret Hamburg, M.D. “There were 299 active drug shortages in the last quarter of 2012, the highest quarterly number to date.”
In the drug manufacturing arena, particularly in the generic drug market, “economic incentives are firmly stacked against investing in plant improvements or redundancies,” AHA told Hamburg. “In the short term, there is little that the FDA can do to counteract these economic disincentives, other than provide for expedited inspections and certification of manufacturers who voluntarily expand their operations to produce drugs vulnerable to or in a shortage, or to reduce and waive required user fees. However, in the longer term, we recommend that FDA and Congress collaborate with the pharmaceutical industry to identify appropriate incentives that would encourage drug makers to establish manufacturing redundancies and invest in their quality systems.”
Preferential tax or patent policies for manufactures of drugs vulnerable to shortages and increased Medicare reimbursement for providers using such drugs are possible strategies, according to the association.
AHA also called for improvements to the FDA’s public drug shortage Web site and for the agency to use its new authorities to support timely approval of generic drugs and expedite federal approval for new sources of drugs that are in shortage. Full text of the letter to the FDA is available here.