In focusing on individual drug shortages, the FDA is missing opportunities to proactively prevent and mitigate shortages in general, according to the Government Accountability Office (GAO).

The “FDA currently uses data on an ad hoc basis to respond to specific shortages as opposed to using the data to identify trends or patterns that may help it predict and possibly prevent shortages,” the GAO told the House Energy and Commerce Subcommittee on Health this week.

Instead of waiting until it develops a new information system to track drug shortages, the FDA needs to routinely analyze the information it has in its existing drug shortage database so it can be more proactive, the GAO said. By identifying risk factors for potential shortages early on, routine data analyses could help the FDA recognize trends, clarify causes and resolve problems before a shortage develops.

The GAO also recommended that the FDA develop policies and procedures to ensure that data are accurately and consistently entered into the database.

While the number of new shortages being reported has dropped from a record high of 255 in 2011, shortages are still occurring, with 195 reported in 2012 and 73 reported as of June 30, 2013. Those GAO numbers are higher than the ones the FDA presented to the subcommittee. Douglas Throckmorton, deputy director for regulatory programs at the FDA’s drug center, testified that 117 new shortages were reported in 2012 and 44 were reported in 2013.

Regardless of the number, the GAO credited the decline to the provision in the FDA Safety and Innovation Act that required manufacturers to notify the FDA of circumstances that could lead to a shortage. Due to early notification, the agency was able to prevent 154 potential shortages in 2012 and 50 through June 2013, the GAO said. (The FDA claimed it prevented 282 shortages in 2012 and 170 in 2013.) (See BioWorld Today, Nov. 1, 2013.)

Notification of possible supply interruptions doesn’t address the underlying causes or resolve ongoing shortages, some of which have lasted for years, the GAO said in its testimony.

The number of active shortages nearly tripled from 2007-2012 – from 154 in 2007 to 456 in 2012, according to the GAO. About half of the shortages in 2012 were considered critical, because alternative drugs weren’t available, the shortages involved several manufacturers or there were multiple reports from different institutions.

As a result, health care providers continue to face “delays in or rationing of care, difficulties finding alternative drugs, risk associated with medication errors, higher costs and reduced time for patient care,” the GAO said.

While manufacturing quality problems – such as bacterial contamination and glass or metal particles in drug vials – are the most frequently cited immediate cause of shortages, there’s some debate as to whether those problems were always the primary trigger for supply disruptions that lead to shortages, the GAO said. Some studies and manufacturers suggested that changes in FDA inspections also were a factor.

But fingering the immediate cause does little to address more pervasive underlying causes. “Half of the studies we reviewed suggested that the immediate causes of drug shortages, such as quality problems, are driven by an underlying cause that stems from the economics of the generic sterile injectable drug market,” the GAO said in its testimony.

Factors such as competition in a generic drug market that’s focused primarily on price, the possible role of group purchasing organizations and a change in Medicare Part B reimbursement policy may all add to the problem. The GAO cited various studies that suggested these underlying causes led to low profit margins, limiting infrastructure investments or forcing some manufacturers out of the market.

CAFA SUIT TO GET REDUX

The U.S. Court of Appeals for the Ninth Circuit will reconsider a September 2013 decision that all but eliminated the right of out-of-state defendants to remove numerous-plaintiff lawsuits from state court to federal court.

The 2-1 decision in Romo v. Teva Pharmaceuticals USA Inc. affirmed a lower court ruling that remanded the case to California state courts, undermining the 2005 Class Action Fairness Act (CAFA) that allows defendants to remove cases with 100 plaintiffs or more to federal court, thereby avoiding discriminatory treatment that out-of-state defendants could face in a state court. (See BioWorld Today, Sept. 27, 2013.)

The case is to be reargued June 16 before an 11-judge en banc panel.

To get around the CAFA mass action provisions, Romo attorneys divided the plaintiffs into several identical lawsuits, which they then sought to coordinate for all purposes. The plaintiffs, many of whom are not California residents, alleged injuries arising from the use of prescription pain medications containing propoxyphene. The opioid drugs, which included Darvon and Darvocet, were withdrawn from the U.S. market in 2010 due to cardiovascular safety concerns. (See BioWorld Today, July 8, 2009.)

FDA TO REVIEW DIABETES DRUG

As a result of a study published in The New England Journal of Medicine (NEJM) a few months ago, the FDA is reviewing the heart failure risk with Bristol-Myers Squibb Co.’s (BMS) diabetes drug saxagliptin, marketed as Onglyza and Kombiglyze XR.

The agency plans to conduct an analysis of trial data it has requested from BMS. The analysis is part of a broader evaluation of all type II diabetes drugs and cardiovascular risk, the FDA said.

The NEJM study compared saxagliptin with placebo in nearly 16,500 subjects who were followed for two years. Researchers found that 3.5 percent of the patients in the saxagliptin group were hospitalized for heart failure compared with 2.8 percent in the placebo group. Rates of cardiovascular death, heart attack or stroke were similar in the two groups – 7.3 percent in the treatment group and 7.2 percent in the placebo arm.

At this time, the FDA said, it considers the information from the NEJM study to be preliminary.

FDA, INDIA SIGN AGREEMENT

FDA Commissioner Margaret Hamburg won’t return from India empty-handed.

“In the spirit of continued collaboration and a commitment to quality,” she said she signed a statement of intent with the Indian Ministry of Health and Family Welfare Monday.

Calling the statement an important milestone, Hamburg said, “Our organizations plan to collectively work together to improve the lines of communication between our agencies and work diligently to ensure that the products being exported from India are safe and of high quality.”

No Comments