By Toni Clarke
Oct 31 (Reuters) - The U.S. Food and Drug Administrationreleased a strategic plan for preventing drug shortages onThursday and proposed a rule to require drug and biotechnologycompanies to promptly notify the agency of potential disruptionsto the supply of medically important drugs.
The plan and proposal come in response to a 2011 order fromPresident Barack Obama to solve the problem of drug shortages.Between 2005 and 2011 the number of new shortages quadrupled to251. That figure declined to 117 in 2012 but there were stillmore than 300 ongoing shortages at the end of the year.
The 2012 Food and Drug Administration Safety and InnovationAct called for the FDA to improve its response to imminent orexisting drug shortages and to address the underlying causes ofsuch shortages. The act also gave the FDA new authority torequire drug manufacturers to notify it of potential supplydisruptions.
The FDA said its proposed rule would extend this earlynotification requirement to include makers of biologic drugs,which are typically complex products made from living organisms.
Most drug shortages are the result of quality controlproblems. The agency said it plans to work with manufacturers tofix such problems and "encourage" them to engage in practicesthat could avoid or mitigate shortages.
The FDA recommended that companies, among other things,design programs to ensure supply is available in the event of ashortage. It also recommended companies build up inventorybefore major manufacturing changes and that they communicatewith contract manufacturers to anticipate problems.
Still, the agency said can only do so much to get companiesto act, and suggested others think of ways to provide incentivesfor companies to improve their manufacturing processes.
"FDA is exploring ways to use its existing authorities topromote and sustain quality manufacturing," it said. "However,our ability to offer financial or other economic means topromote innovation in quality manufacturing is limited."
The FDA said groups that buy drugs, such as hospitals andgroup purchasing organizations, rarely take quality into accountwhen making purchasing decisions, and it recommended theyexamine publicly available information about a company's qualityrecord.
"This decoupling of quality considerations from purchasingdecisions makes cost the major factor in purchasing decisions,"the FDA said, "most likely intensifying price competition,leading manufacturers to focus more on reducing costs than onmaintaining quality."
The agency said it cannot require companies to build inextra manufacturing capacity to guard against shortages, ororder a company to make a product if it is not profitable, butit invited "other stakeholders" to consider how to reward highmanufacturing standards.
The FDA said that since the president's order there has beena six-fold increase in notifications about possible shortages.It said it helped prevent 195 drug shortages in 2011 and 282drug shortages in 2012.
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