This just in from FDA…. The Food and Drug Administration (FDA) today completed its safety assessment of Ketek (telithromycin) and is advising health practitioners and patients to be aware of rare but potentially serious health risks. (more…)
Who says FDA isn’t enforcing anymore? But seriously folks, this news just arrived…note the recurring phrases ”lack of control” and “CAPA inadequacy.” Clearly FDA is focusing on process knowledge/understanding in its evaluations. The U.S. Food and Drug Administration (FDA) today announced that Baxter Healthcare Corp. (Baxter) and two of its top corporate executives have signed a consent decree of condemnation and permanent injunction for certain infusion pumps made by the firm. They agreed to stop manufacturing and distributing within the United States all models of the Colleague Volumetric Infusion Pump (Colleague) and the Syndeo Patient Controlled Analgesic Syringe Pump (Syndeo) until they correct manufacturing deficiencies and until the devices are made in compliance with FDA’s current good manufacturing practice (CGMP) requirements and the Quality System (QS) regulation for devices. (more…)
Eli Lilly will eliminate 550 jobs at its Basingstoke, U.K. facility, 300 jobs at its Belgian research facility, and positions at its research site in Hamburg. All three facilities will be closed, the company says, although Lilly reportedly plans to open a distribution facility and headquarters near Frankfurt.
-AMS
Spam is part of 21st century life, and pharma is a key target. But—-apologies for a brief Andy Rooney-like rant— just learned that some spammer out there is sending junk mail out on our behalf. Our IT sleuths are on the case, and will put a stop to this soon. But if you receive any questionable email from me, PharmaManufacturing.com, or ”the team at Putman Media” I’m sure that you will realize that it is not from us, and that we’ll do all we can to prevent it from recurring in the future.
I have to marvel at the inconsistency of spam filters and corporate IT security systems. As it stands, our firewalls and yours are blocking valid emails every day, preventing legitimate information from being released—-a notice about an upcoming “Process Expo,” for instance, really kicked the spam filters into high gear last week.
We’ve learned never, ever to refer to her country of origin when we cover anything relating to Ms. Akunyili of NAFDAC. Pfizer’s star ED product must be referred to as “the little blue pill,” until the company’s next blockbuster happens to be made in blue.
Yet we still manage to receive messages like the “urgent” email I just got from John Ibe, Barrister in Nigeria, requesting help and my bank account number, the happy notices of million-dollar-sweepstake prizes, or the two “marriage proposals” I received from two nubile young women from Russia, complete with pictures. Not to mention the onslaught of extremely offensive emails with plausible sender names and subject lines—Re: your email, or Re: upcoming meeting, or phishing messages, including some purported to be from our own IT department.
To paraphrase Howard Beale, the dotty but righteously angry anchorman in the old flick Network, “We’re mad as hell” about spam. But , unfortunately “not taking it anymore” would mean cutting off all digital communications and e-contact. So I guess we have to live with it.
In the meantime, here’s wishing that your internet travels and email communications be as safe and private as they can be.
-AMS
Below, an official response to Waxman’s Report from David Elder, Director of FDA’s Office of Enforcement.
“FDA enforcement cannot be properly judged by counting the number of actions taken by the agency. FDA has increasingly used an enforcement strategy based on efficient risk management principles that focuses on combating the greatest public health risks and maximizing our deterrent effect against potential violators.
As a result of FDA’s focus on those firms and those violations that present the highest risk to consumers and public health, the agency has taken prompt, targeted and aggressive action against firms that are in violation of law.
Importantly, such action has resulted in Court findings in support of FDA. Court rulings favorable to FDA send regulated industry a strong message that FDA is serious about industry compliance and act as an effective deterrent.
Further, in recent years FDA has worked to strengthen warning letters and make companies clearly understand that failure to heed a warning letter will likely result in further enforcement action.
Over the past few years FDA has won a string of unprecedented legal actions against firms that were found to be in violation of the law. These include settlements and penalties against a whole spectrum of violators. Criminal fines and restitutions resulting from FDA’s enforcement actions alone since FY 2000 have amounted to more than $2.5 billion – a figure that exceeds the agency’s annual budget.
Recent years have seen record FDA enforcement actions. These include a case against a major pharmaceutical company in 2002 that resulted in a $500 million civil fine, the largest in agency history. In 2005, FDA enforcement efforts against another pharmaceutical company resulted in the largest seizure in FDA history – a seizure of nearly $1 billion worth of goods.
The deterrent effect of these and other targeted actions can be seen in a number of ways including a small but steady decline since FY 2000 in the rate of serious violations encountered in FDA inspections of regulated firms.
FDA is constantly working to improve its enforcement efforts by improving its management of enforcement activities and by bringing state-of-the-art science and risk based management principles to our enforcement work. “
-AMS
Dell is now investigating why one of its laptops spontaneously burst into flames at a conference in Japan last week. Read all about it.
-AMS
Henry Waxman’s official statement on FDA’s 100th anniversary noted his concerns that the Agency is now “adrift.” His Committee on Government Reform outlined these concerns, in great detail, in a recent report, “Prescription for Harm,” based on over 15 months of document review.
Among other things, the report notes that FDA enforcement activity has decreased substantially during the Bush years. Between 2000 and 2005, the report says, the number of warning letters issued to companies fell 50%, he notes. Enforcement and recordkeeping have been lax as well, the report alleges, while eforcement officers have appeared to ignore field inspector’s suggestions. (Click the link above for more information and a PDF of the full report).
Does this reflect the Agency’s new focus on risk-based prioritization of enforcement activities, internal politics and a learning curve as traditionalists within the Agency adapt to the new way of doing things?
Or is the Agency simply understaffed, underfunded and overextended? You be the judge.
If these findings reflect FDA’s new approaches to enforcement and regulation, rather than underlying problems, then couldn’t the Agency improve its communication and outreach to the public and regulators?
Of course, if insufficient resources are the root of the problem, other remedies will be needed. But FDA’s zealous enforcement in the pre-Bush era didn’t appear to do much good, either—ironically, the number of Consent Decrees issued to drug companies hit a record level during the 1990s, which helped neither the industry nor the Agency.
Here’s what Peter Pitts had to say about this on DrugWonks. What do you think?
-AMS
Roger L. Williams, M.D., executive vice president and CEO of the U.S. Pharmacopeia (USP), today offered the following statement on the 100th anniversary of the U.S. Food and Drug Administration (FDA):
“USP is pleased to honor FDA on its centennial anniversary and congratulates all FDA staff, current and previous, who have contributed to FDA’s long and distinguished history.”
USP has been an active participant in the FDA centennial celebration. At the FDA Science Forum held April 18–20, 2006 in Washington, DC, USP provided a number of poster presentations. Topics included “USP and FDA: A Century of Collaboration,” “Compendial Science and FDA: Promoting Public Health,” and several other scientific topics.
“Although USP is independent of FDA, we share a common goal of serving the public health. USP works closely with many other organizations, agencies, regulatory and health care entities, practitioners, and industry representatives in the U.S. and around the world. Our working relationship with FDA is particularly important in serving the U.S. public, and we look forward to the next 100 years of our collaboration with FDA.”
Just one point where the two groups appear to diverge: process analytical technology (PAT). Stay tuned for more coverage in Pharmaceutical Manufacturing and its web site.
-AMS
Thomson Scientific will soon be launching a “Generic Competition Module,” designed to allow name-brand drug manufacturers to identify and assess the potential impact of generic competition on their products early in the development cycle.
-AMS
[This may seem like a very "commercial" post, but we sense the need for strong online pharma manufacturing training programs, beyond what the generalist programs (e.g. University of Phoenix) may offer, and want to let you know about a new partnership between our magazine, web site and Stevens Institute...]
Pharma professionals, based anywhere in the world, who are looking for a relevant, rigorous ONLINE graduate study program will find a wide selection of online accredited graduate courses on pharmaceutical manufacturing, management and technology at the Stevens Institute in Hoboken, N.J.
Stevens courses are available to qualified professionals based anywhere in the world, and feature a robust interactive IT platform [we know because we've tested it] that facilitates communication between students and teachers, and between students.
If you’re interested in signing up for a September class, Stevens will offer a 10% discount off the registration fee to subscribers to our magazine, or registered visitors to www.PharmaManufacturing.com (registration is free and takes two minutes or less).
Here is a listing of relevant courses, all of which can be taken at home, from your own PC, and at your convenience (please note, though, that exams and assignments are scheduled…these are not “passive” prepackaged courses):
Online via Stevens WebCampus (classes start week of Sept. 4)
Pharmaceutical Manufacturing
PME 530 WS - Introduction to Pharmaceutical Manufacturing
PME 539 WS - Bioprocess Technology in Pharmaceutical Manufacturing
PME 540 WS - Validation and Regulatory Affairs in Pharmaceutical Manufacturing
PME 541 WS - Validation of Computerized Systems
PME 560 WS - Quality in Pharmaceutical Manufacturing
PME 600 WS - Engineering Economics and Cost Analysis
PME 609 WP - Introduction to Project Management (Customized for the Pharmaceutical Industry)
Pharmaceutical Management
PME 530 WS - Introduction to Pharmaceutical Manufacturing
MGT 681 WS – Managing Pharmaceutical R&D
Project Management/Technology Management
MGT 609 WS - Introduction to Project Management
MGT 610 WS – Strategic Perspectives on Project Management
MGT 612 WS – The Human Side of Project Leadership
MGT 614 WS – Advanced Project Management
MGT 656 WS – Total Quality Management
MGT 641 WS – Marketing Management
MGT 671 WS – Technology Management
Systems Engineering
SYS 611 WS – Simulation & Modeling
SYS 612 WS – Project management of Complex Systems
SYS 625 WS – Operational Effectiveness and Life Cycle Analysis
SYS 640 WS – System Supportability & Logistics
Please visit Stevens’ WebCampus web site for a complete course roster, and call or fax Stephanie Robinson at Stevens via the numbers below for more information.
Tel: (201)216-5092 or (800) 496-4935
Fax: (201)216-5011
You can also email her for more information. (And please remember to mention PharmaManufacturing.com to receive the discount).
Heads up: Accredited executive education courses, offering CEU credits, are now in the works. Stay tuned for more on this soon.
-AMS
