U.S. FDA Begins to Initiate Increased Regulatory Powers- A Painful Awareness for Industry Players
If producers of pharmaceutical of food products had any doubts as to the new powers and extended reach of the U.S. Food and Drug Administration (FDA) under the 2011 extended food safety law, there was ample evidence demonstrated last week.
India based generics drug producer Ranbaxy Pharmaceuticals Inc. was forced to voluntarily halt production of the generic equivalent of the highly utilized cholesterol drug Lipitor while it continues to investigate how tiny glass particles were introduced in some production batches. According to various syndicated business and social media reports, the recall was due to “possible contamination with very small glass particles similar to the size of a grain of sand.” The suspension involves certain lots of the 10mg, 20mg and 40mg dosage strengths of atorvastatin tablets, according to the FDA. The FDA took the step of halting the production of foreign produced Ranbaxy generic atorvastatin from the extended powers granted in the 2011 law to halt imports of drugs from foreign based producers suspected for having a history of quality deficiencies that could injure or harm patients.
Ranbaxy has been operating under increased FDA scrutiny because of reported quality lapses involving multiple Ranbaxy facilities dating back to as far as 2006. In 2008, the FDA barred the drug maker from shipping over 30 different drugs produced at troubled factories in India and would not consider any new applications from Ranbaxy to sell drugs in the U.S. that were produced at these troubled factories without firm evidence of remediation and conformance to documented Good Manufacturing Principles.
According to a report published on the India based Daily News and Analysis site, generic Lipitor has been one of the biggest bets for Ranbaxy, bringing in $600 million from December-May 2012 when the company monetized its exclusivity opportunity in the US. Post the completion of the exclusivity period, the company managed to retain a share of 45-50% on the generic equivalent to Lipitor. On Friday, the headline of the Ranbaxy recall permeated traditional broad based and social media, most likely adding further damage to the Ranbaxy brand image for U.S. consumers.
Also last week, contrary to the intentions of peanut products producer Sunland Inc., the FDA continued to halt operations of the largest organic peanut butter processor in the U.S. because of continued concerns for salmonella poisoning somewhere within the supply chain. The FDA had discovered elements of salmonella at a Sunland New Mexico processing plant after 41 people across 20 U.S. states were sickened by peanut butter manufactured by Sunland for hundreds of products offered under other brands, including the Trader Joe’s brand, as well as Target Stores Archer Farms brand, and the Costco Kirkland Natural Peanut Butter brand. The original recall issued in late-September included peanut butter and other nut butter products produced in a separate building from where raw and roasted peanuts are processed. An extension of the recall was announced on October 12th as a result of a joint investigation by Sunland and the FDA, and included both peanut butter and raw and roasted peanuts produced by Sunland.
The enhanced food safety law gave the FDA authority to suspend a company’s registration when food manufactured or held has a “reasonable probability” of causing serious health problems or death. Before the food safety law was enacted early last year, the FDA would have had to go to court to suspend a company’s registration.
In social media, the widely read Huffington Post commentary included the following paragraph:
“FDA officials found salmonella all over Sunland Inc.’s New Mexico processing plant after 41 people in 20 states, most of them children, were sickened by peanut butter manufactured at the plant in Portales and sold by Trader Joe’s grocery chain. The FDA suspended Sunland’s registration Monday, preventing the company from producing or distributing any food.”
Sunland had voluntarily closed its plant after the September outbreak and planned to reopen its peanut processing facility on Tuesday of last week, with hopes of selling peanut butter again by the end of the year. Media reports quote Sunland as indicating that the FDA suspension was a surprise to the company and Sunland officials had assumed they were allowed to resume operations. The company now has the right to a hearing and must prove to the agency that its facilities are clean enough to reopen.
Meanwhile, Sunland and organic peanut product brands are once again tainted by mass media reporting that continues to note concerns for salmonella.
The overall message is for pharmaceutical and food producers to internalize that the FDA has increased powers to now enforce food safety, and that the agency intends to exercise these powers throughout the supply chain.