Houston Drug Injury Attorneys Urge Stronger FDA Drug Making Oversight

As of last count, the fatal fungal meningitis outbreak linked to the NECC (New England Compounding Center) compounding pharmacy had killed 23 and sickened more than 280 patients in 16 U.S. states. More than 14,000 patients might be at risk, and the outbreak is still in its early stages. The fatal fungal meningitis can takes weeks to show symptoms in the body.

Contact the Houston Drug Injury Attorneys at Denena & Points if You’ve Received a Contaminated Steroid Injection

If you or a loved one has been affected by the contaminated drugs from the NECC or you have become ill, we request that you contact us to report it. In our ongoing efforts to enhance drug safety efforts, we are seeking people who received the recalled drugs so that the FDA has an accurate count of how many people have been affected. Fill out our “Get Help Now” form online or call us toll free at 877-307-9500 to reach us.

Stronger Oversight of Drug Imports and Manufacturing by the U.S. FDA is Needed to Keep U.S. Patients Safe from Harm

Currently, the medications you take are a product of a vast and largely unregulated global network of raw materials suppliers, brokers, re-sellers, chemical producers, manufacturers, and distributors. Several countries might have been involved in the production of the pharmaceuticals that you take you for your illness. But the FDA will only have oversight authority over some of them.

Even those companies over which the FDA has authority might never have been inspected or might have been inspected only once in more than 10 years. Observation has shown that where companies can escape sound oversight, they will sometimes take chances with people’s safety.

Authorities aren’t saying yet how the fungal contaminants came to be in the recalled NECC drugs that have killed more than 20 people so far. Investigators may not know that answer yet. But patients have apparently been sickened not just by the injectable steroid, but also by a cardioplegic medication from NECC.

Some of the Dangerous Safety Gaps in Current Regulatory Oversight:

• The U.S. FDA may not enter foreign facilities unannounced to inspect them. (It can enter U.S. facilities unannounced to inspect.)
• U.S. regulations mandate that the FDA inspect U.S. pharmaceutical facilities every two years. No similar requirement exists regarding foreign facilities and up to 2/3 of them have never been inspected by the FDA.
• Companies that don’t export their products directly to the United States don’t have to register with the FDA even though their products might enter the U.S. market through a third party (such as when a registered exporter includes ingredients from a non-registered company in its drug).
• FDA oversight of drug ingredients only applies to the manufacturing process and not to other production steps like collecting and extracting source materials.
• FDA oversight applies to ACTIVE ingredients. The inactive ingredients (excipients like flavoring, fillers, and preservatives) that might make up the bulk volume of your drug are only evaluated during the FDA approval process for a new drug. So if a new supplier begins to supply excipients and it is less careful than the one involved at the approval stage, your drug might suffer contamination.
• There is no national track and trace program for prescription drugs to prevent substandard or counterfeit drugs from reaching patients or to notify patients who might have come into contact with contaminated drugs (NECC steroid injections for instance). Medical facilities all over the United States are jumping through hoops now trying to figure out who might have received possibly contaminated NECC products. It’s a slow process without a track and trace program, and only time will tell if the health industry reaches all infected patients in time.
• The FDA cannot recall unsafe drugs on its own authority. It must rely on manufacturers and distributors to make voluntary recalls of the products. (Source: Detroit Free Press, 10/21/12)

As you might perceive, many safety gaps still exist in the U.S. regulatory process that oversees drug safety. Your health is at risk. So is mine. So the Houston drug injury attorneys at Denena & Points join other concerned parties in urging stronger FDA oversight of the drug manufacturing and supply process.