September 19, 2014—Manufacturing disruptions are one of the most cited reasons for generic sterile injectable drug shortages, the journal Health Affairs reports in a new policy brief. Common problems include the inability to obtain raw materials from foreign sources, discovering quality issues such as foreign particulate in the product, or prolonged efforts to upgrade and modernize factories. [ms-protect-content id=”2799″]”These types of situations particularly affect these drugs because of the low number of generic manufacturers in the market and their lack of surplus capacity,” it notes.
In a congressionally mandated report last February, the Government Accountability Office similarly concluded that halts or slowdowns in manufacturing to address quality problems are the leading immediate cause of drug shortages, especially among generic sterile injectable products.
“While newly reported drug shortages overall are decreasing, the total number of drug shortages continues to increase,” the new Health Affairs article observes. “These trends call into question what additional steps can be taken by private industry, government, and other stakeholders to ensure sufficient drug supply in the future.”
Other factors identified in contributing to generic sterile injectable drug shortages, it says, include “arduous new drug approvals” that delay production, patent expirations that may reduce profits and thereby change companies’ production strategies, and unexpected increases in demand.
“Some health policy analysts have also asserted that government-mandated discount programs such as Medicaid and the 340B drug discount program act as price controls, negatively influencing the profit potential of drug manufacturers, inhibiting their ability to invest in factory upgrades and thus contributing to drug shortages,” the article notes. “Supporters of Medicaid and the 340B program point out that there is no evidence to suggest that these federal programs cause generic drug shortages,” it adds, “especially considering that industry groups and government reports have not named these government pricing programs as a cause for drug shortages.”
Health Affairs adds that a congressional proposal to exempt certain generic sterile injectable drugs made by fewer than three manufacturers from these pricing programs made no headway when it was introduced.
The bill, sponsored by Rep. Bill Cassidy (R-La.), would have exempted most generic sterile injectable products from 340B discounts and Medicaid rebates through 2020. Sen. Orrin Hatch (R-Utah) circulated but never introduced similar draft legislation. [/ms-protect-content]