Good News/Bad News For Excedrin, Interceptor Users

Process validation is under way for Excedrin at the Novartis manufacturing facility in Lincoln, Nebraska, according to company CEO, Joseph Jimenez. That’s the good news.

The bad news for long-suffering devotees of this over-the-counter pain relief medicine is that the product will not be available in stores until October.

Jimenez gave this update during the Novartis 2nd Quarter conference call earlier today (July 19th). In addition to Excedrin, the company is in the process of product validation for Sentinel, a heartworm prevention pill. It, too, should ship before year-end.

Bad news for many pet owners is that Interceptor, a heartworm prevention pill that competes with Sentinel and also was manufactured at the same production facility, was not mentioned at all during Jimenez’s presentation. This does not bode well for its return to the marketplace in the near future. One San Diego veterinarian was told by his wholesale supplier not to expect Interceptor back on the market before 2013. The supplier’s representative explained that Sentinel, which contains the same active ingredient as Interceptor, is a higher margin product for Novartis and will have priority over the less profitable drug.

Novartis announced a massive product recall and was forced to halt production at the Lincoln plant in January 2012, as a result of packaging mixups and broken or chipped pills. An FDA inspection carried out in January found numerous repeat violations and deficiencies in the plant’s operations and quality control systems. It is taking the company several months longer than it originally hoped to address all of the issues listed in FDA’s 23-page long inspection report. But the end is apparently in sight.

Excedrin users will just have to hang on for a few more months…..

Excedrin & Interceptor – Back By Mid-Year?

Novartis has restarted manufacturing some products at its Lincoln, Nebraska facility. But the popular Excedrin OTC meds, and veterinary products such as Interceptor, are not yet in production.

According to a recent article in the Lincoln Journal Star, production of Opana tablets and morphine sulfate extended released has resumed. Novartis manufactures these, and other, prescription medicines under contract for Endo Pharmaceuticals.

As devotees of Excedrin and Interceptor (a veterinary medication used to prevent heartworm in dogs and cats) know, waiting for these products to return to market has been an exercise in patience.

And trying to find out when Novartis might resume production of these meds is an exercise in frustration.

On January 8, 2012 Novartis Consumer Health, Inc. recalled all lots of Excedrin, NoDoz, and other OTC products manufactured at its Lincoln, Nebraska production facility, and announced that it was suspending operations at the facility in order to “accelerate maintenance and other improvements” at the Lincoln operation. The shutdown affected the availability of a number of other human and animal meds that were produced in Lincoln, including the popular Interceptor heartworm preventative.

The recall and plant shutdown coincided with a scathing inspection report released by FDA in January. The report detailed numerous significant quality control problems at the Lincoln plant – many of them repeat observations first noted during earlier inspections.

Novartis has been close-mouthed about its timeframe for restarting production in Lincoln. According to a Novartis news release, the company told shareholders during its February 23rd Annual General Meeting that it was assuming a “…mid-year start of shipments out of the Lincoln plant.” But, two sentences later, the news release alluded to the possibility of a delayed start-up of Lincoln.

The only other clue to the start-up timeline comes from a March 16th letter to veterinarians, reported by the VIN News Service. In that letter, Novartis is reported to have acknowledged “a backorder situation” resulting from the Lincoln shutdown, affecting the popular veterinary products Interceptor Flavor Tabs and Sentinal Flavor Tabs. According to the VIN report, veterinarians were told that exact timelines for product availability remained uncertain. “We hope,” the Novartis letter is quoted as saying, “to be able to give you a definitive date for a restart within the next few weeks.”

On March 22nd, I sent a request for information by email to the Novartis recall email address, asking for any available information regarding the status of the Lincoln facility. On April 10th, I received a reply from Novartis Consumer Health spokesperson, Millicent Brooks. “In response to your inquiry,” she wrote, “we are working hard to resume production at our Lincoln facility and return OTC and Animal Health products, including Excedrin and Interceptor, to consumers as soon as possible.”

Some Excedrin users have reported purchasing the product on eBay. I would strongly advise against this option. There is no way of knowing whether the product being offered is authentic, or whether it has been stored under proper conditions.

Novartis will be releasing its next quarterly report to shareholders on April 24th. Let’s hope that the report will include an update on the Lincoln status, and that the news will be good.

FDA Fines American Red Cross Another $9.6 Million

For the second time in less than 2 years, FDA has levied fines of more than $9 million on the Biomedical Services arm of the American National Red Cross.

The fines are due to violations by the Red Cross of a 2003 Amended Consent Decree of Permanent Injunction. FDA and the Red Cross entered into the 2003 Consent Decree after FDA inspections of various Red Cross biomedical facilities found numerous deviations from FDA law, regulations and the requirements of an earlier (1993) Consent Decree. The biomedical facilities are responsible for ensuring the safe collection, screening, handling and distribution of the nation’s supply of donated blood.

On June 17, 2010, FDA informed the Red Cross that the non-profit organization was to be fined $9,776,000 for violations of the Consent Decree that occurred from 2003 to 2008. The second series of fines, announced on January 13, 2012, covers violations that were documented during a series of inspections carried out from April 2010 through October 2010.

All told, FDA has fined the American National Red Cross $19,368,200.

A number of the violations that were documented during FDA inspections of 16 different Red Cross Blood Services facilities threaten the potential safety of the nation’s donated blood supply. Here are just a few of the more egregious lapses:

Failure to establish, implement and continuously maintain managerial control over QA in all regions and laboratories…
QA programs were not adequate to ensure that all regulated donor management operations were being performed effectively at the Philadelphia DCSC…
Failure to comply with reporting requirements…
Inadequate National Donor Deferral (high-risk donor screening) Register…
Failure to promptly implement adequate corrective actions to prevent recurrence of the failure to control suspected blood or blood components…
Failure to follow Standard Operating Procedure…
Failure to establish and maintain a distribution and receipt procedure that includes a system by which the distribution or receipt of each unit of blood can be readily determined to facilitate its recall, if necessary…
Failure to ensure that supplies are used in a manner consistent with the manufacturer’ s instructions, and failure to prepare the phlebotomy site using a method that gives maximum assurance of a sterile container of blood…

FDA also underscores in its most recent letter to Mr. Chris Hrouda, Executive Vice President of Biomedical Services for the American National Red Cross that many of the violations enumerated in the January 13, 2012 letter are “virtually identical” to violations reported in previous letters.

As of March 2010, the adult population (15 years of age and up) of the USA was approximately 242 million people. According to the Red Cross web site, 3 out of every 100 Americans – that’s roughly 7.25 million people – are blood donors. I wonder how those 7.25 million people feel about the way the Red Cross is handling their precious Gift of Life.

The American National Red Cross depends on the good will and generosity of millions of people who donate their time, money, and blood to save the lives of total strangers. It’s time that the organization was held to account, not just by FDA, but also by the people on whose generosity it relies for its very existence.

Next time the Red Cross contacts me to ask for a donation, I plan to demand an accounting of how they propose to clean up their act. I suggest that everyone do likewise.