What industry news have you been reading this month? At FDAzilla, we’ve compiled the most noteworthy articles we’ve come across in the weeks since our last update. This month’s picks include information from two conferences, surprising warning letters abroad and in the US, an explanation QSIT protocol, and stories of both exemplary and reprehensible strategies from companies dealing with in-house deficiencies. Take a look:
- Quality issues account for two-thirds of shortages (NOTE: You must select “Yes” in the pop-up window to read the article) Recently at the Biopharma Ambition Conference, Dr. Michale Kopcha, Director of Pharmaceutical Quality with the FDA, spoke about the significant role quality control plays in causing drug shortages. Kopcha argues that updating technologies in the industry could decrease the frequency and number of drug shortages by reducing the amount of quality issues that are currently prevalent in pharmaceutical manufacturing. This article highlights some of Kopcha’s specific criticisms – for example, he notes that some current technology in manufacturing dates all the way back to World War II. It also reviews his suggestions for advancing technology, including his emphasis on the importance of partnership and collaboration between firms and the FDA to push the industry into the technological present.
- ISO 13485: Ex-FDA Official Kim Trautman Gives Advice on Transitioning: Here’s another piece of advice from a recent conference – this time, it’s from Kim Trautman, medical device quality systems expert and former FDA official, who spoke at RAPS 2016 Regulatory conference on ISO 13485:2016. The ISO realized the revision to 13485:2016 this February, but has established a 3-year transition period to give companies time to adjust. — Trautman’s words of wisdom? Don’t use that extra time if you don’t need it. Switch to the new standards as soon as possible. None of us want to make the change, but if your company doesn’t start now, it will suffer later. The article reviews the details of ISO’s transition phases, and highlights the specific changes Trautman says your company should look out for as you switch to the new standard.
- Understanding the 4 Types of FDA Inspection:This article’s focus is on the inspection of medical device manufacturers, but is a good overview of inspection protocol for all sectors. Peter Ohanian of Halloran Consulting reviews the four types of FDA inspections — pre-approval, routine, compliance follow-up, and “for cause” – and explains when and how they occur. After this refresher, Ohanian dives into a detailed explanation of Quality System Inspection Technique (QSIT) to help you know how to prepare for and what to expect from your own FDA inspections. Did you know the FDA decides which firms to inspect based on risk classification? Can you name the four subsystems the QSIT identifies? Do you know what differentiates an abbreviated from a baseline inspection? If not, this piece might be worth a read.
- Does an FDA Import Alert Equate to an FDA Warning Letter?: The short answer to this question is “no” — but this article looks at the reasoning and nuance behind that response. For example, how strong is the correlation between Warning Letters and Import Alerts? GMP Quality Expert Barbara Unger has tabulated FDA data on Import Alerts and associated Warning Letters. This information, presented in three tables and a graph of raw data, is used to determine the statistical strength of the relationship.
- ‘The Rooms Had Never Been Cleaned’: Two New FDA Warning Letters for Chinese Manufacturers:This article reviews warning letters recently issued by the FDA to Chen Fong Chemical and Hebei Yuxing Bio-Engineering, two Chinese API makers. The problem? Data Integrity and GMP violations – a common reason for FDA enforcement action, particularly in overseas plants. The FDA is issuing an increased number of Warning Letters to overseas manufacturers in general, with 16 of the 25 issued this year being addressed to firms in either China or India. Read this story for a list of the startling details from these Warning Letters, which include phrases like “leaks,” “insects,” “dirt,” and “microbial contamination.” Links to the original documents can be found at the end of article.
- FDA Warning Letters: Pests, Seafood HACCP Issues, Drug Residue: In case we’ve given you the impression that everyone getting in trouble with the FDA is based overseas, this article should clear that up. While it might be true that “rodent droppings” and “live insects” have recently been associated with manufacturers in India and China — this time it’s right here in the USA. Food Safety News covers warning letters recently issued to a multitude of local companies, including Chicago’s Indoor Garden, SuperValu Inc., Frontier japan Inc. (for their seafood importer in NYC), Arcadia Trading Inc., Varel Farms LLC, and Tensen Dairies LLC. The violations listed in this piece are gross in multiple senses of the word. For example, in Chicago, one of the FDA’s criticisms was an employee who “repeatedly wiped their nose with gloved hands and then returned to packaging the [finished vegetable product] without washing or changing gloves or washing their hands.” If you were disturbed by the insect boor holes in the last article, this should make you even more uncomfortable.
- J&J Warns Diabetic Patients: Insulin Pump Vulnerable to Hacking: How can a security defect in your product end with public praise from the FDA? It’s all about how you address the problem, and Johnson and Johnson’s approach to a recent cyber vulnerability is an exemplary illustration of how to handle similar situations. Reuters reports that J&J was made aware of a possible security hazard in their Animas One Touch Ping insulin pump earlier this year. According to J. Radcliff, the Rapid7 Senior Security Consultant who informed the company of the problem, hackers could potentially overdose diabetic patients due to the fact that the device’s remote control release feature is not encrypted or scrambled. What did J&J do about this? Neither J&J nor the FDA know of any attempted hacking attacks on the device. In fact, J&J described “the probability of unauthorized access” as “extremely low.” Nevertheless, after working with Radcliff to examine assess the risk, the company released letters to doctors and patients warning them about the threat and providing steps to prevent possible attacks. What did the FDA have to say about this approach? The FDA is currently developing formal guidance on how medical device makers should handle reports about cyber vulnerabilities. Apparently, this is exactly what they want. An agency statement published the day after J&J’s letter reads, “this is the proactive behavior the FDA has been looking to see.”
- FDA Warns Japanese Company for Impeding Inspection: If you pay attention, everyone teaches you something. Sometimes you learn what to do, and sometimes you learn what to avoid. If the last article showed us the ideal way to handle problems within your company, the actions of Nippon Fine Chemical Co. recorded here demonstrate the worst possible approach. During their inspection, employees — under the direction of management! — physically blocked inspectors from entering certain areas of the facility, refused to deliver their records, and would not allow the officials to take photographs. If the company was trying to avoid enforcement action by hiding their mistakes, they didn’t succeed. Instead, they compounded their problems by trying to conceal them. FDA issued a Warning Letter in which they found Nippon in violation of CFR 21 Section 351(j). Shipments from this facility will be refused until an inspection can be made successfully.
- FY 2016 Generic Approvals by FDA: A New Record Under GDUFA:The results are in: the FDA approved 159 more ANDAs (abbreviated new drug applications) in FY 2016 than it did in FY 2015 (and 242 more than in 2014). But does this indicate increased leniency toward new drug proposals? Nope. Instead, these numbers reflect an increase in the rate at which the FDA is reviewing applications. How do we know? The number of ANDA approvals rose this year only because the total number of response letters increased overall. In fact, the FDA sent more complete response letters in FY 2016 than in any other previous year. They issued 1,725 in total, which is up by 545 CRLs from 2015. This means that while the number of approvals increased this year, so did the number of rejections. This increased review rate is intentional – it’s a result of the FDA hiring almost 1,000 new employees this year to help fight the backlog of ANDAs the FDA has been working against since 2012. It’s also an area where the FDA hopes to continue improving. According to the GDUFA I performance goals for the coming year, the FDA hopes to “review and act on 90 percent of complete electronic ANDAs within 10 months after submission.”
- Teva’s Ranbaxy-like Mess Builds Up in Mexico: It’s been less than a year since Teva purchased Rimsa, a leading pharma manufacturing and distribution company in Mexico, but writers at PharmaCompass argue that parallels between this acquisition and the events we saw in the 2008 Ranbaxy debacle are already “strikingly” clear. To say the transition has not been smooth would be an understatement. Both parties – the former owners ofRimsa, Fernando Espinosa Abdala and Leopoldo de Jesus Espinosa Abdala, and its current owners at Teva – have filed legal complains against the other. The Abdalas claim that Teva is experiencing “buyers remorse” and is looking for ways to reverse the transaction “by any desperate measure.” The problems at Rimsa, which Teva listed in their 52-page complaint, resemble many of those found at Ranbaxy. PharaCompass has compiled a helpful table, found in the middle of the article, which summarizes the similarities between the two ordeals.
What recent events do you think are important to our industry? Is there a story we missed? Are there specific topics you’d like to see covered? Let us know in the comments!
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