The U.S. Food and Drug Administration’s Minneapolis District Office generated just a single device-related warning letter in 2010 after more than 140 inspections in Minnesota, Wisconsin and the Dakotas.
Those were among the numbers shared Wednesday at an annual breakfast with local FDA leaders. The event, sponsored by LifeScience Alley, was the first opportunity for some to hear from Minneapolis District Director Gerald Berg, a St. Paul native who assumed leadership of the local office in August.
That lone warning letter in the device category is the smallest yearly total that compliance officer Tim Philips can ever remember. He began his explanation by taking an opportunity to pat his audience on the back. “I think by and large we have a pretty good industry here,” Philips said.
He added, however, that the low number probably also signals a need to improve operations at the local office, which has dealt with turnover and training distractions while nearly doubling its inspection staff since 2008.
The breakfast event is more about networking than newsmaking, and a moderator noted at the outset that the 510(k) topic wasn’t on the agenda. Instead, Berg began with a broad overview of the office and its mission.
“It’s certainly good to be back home,” said Berg, who began his FDA career as an investigator in Dallas and most recently worked in the Chicago office.
“The best way to characterize the state of the Minneapolis District Office here is: it’s improving,” Berg said. The office is settling into its new space on Marquette Avenue in downtown Minneapolis. It’s seen “a little uptick” on some of its budget lines, and recently won new food safety authority from Congress.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Berg echoed some of the recent tone from Washington about the importance of not only protecting the public but also facilitating innovation. “We can’t have a system that is so stringent that it doesn’t allow new products,” he said.
He spoke about balancing risks between protecting patient safety and providing them access to new products and treatments, but he also left no doubt that public safety comes first.
Berg spoke about the FDA’s efforts to speed up the issuance of warning letters and conduct follow-up inspections within six months of enforcement. He also asked industry for help by responding to 483 letters within 15 business days or sooner, if possible.
Philips and inspections supervisor Rhonda Mecl each drilled down into the office’s 2010 numbers.
The district’s 92 inspectors conducted about 600 investigations, which generated 21 warning letters. Of those, 17 went to food companies, three went to drug makers, and one went to a device company (Frontier Medical Products, a Wisconsin company called out for six violations.)
Another 35 device companies received less-severe 483 letters, which give recipients time to correct problems without any punitive action.
Mecl said that her staff is “pretty stable” now, but nine of her 14 medical device inspectors have less than two years of experience. Overall, the office’s inspection staff has grown from 49 in 2008 to 92 today.
