This month saw the first glimmers of FDA's new "get tough" policy with the firms it regulates. FDA Commissioner Dr. Margaret Hamburg laid out six policies that will go into effect over the next few months:
1. Firms are expected to respond to 483 observations within 15 days
This dovetails with the requirement for inspectors to forward their recommendations from the field as to whether or not a firm should get a warning letter or other enforcement action.
Unfortunately for executives who'd rather outsource a response to consulting companies that specialize in helping firms respond to 483s to avoid warning letters (a claim, I'd add, that few consultants back up with a money-back guarantee), 15 days is not a lot of time. In that short span, you'd have to find the consultant; evaluate and qualify the consulting firm; craft non-disclosure contracts; write, revise, and sign the statement of work ... oh, AND also actually respond to the 483s.
If my experiences hold true of being called in to help clients AFTER the mess created by the "we'll save you with our awesome response" consulting firm back when the response time was 30-90 days, I'm thinking it's going to get a lot worse for drug, device, and biologics companies. After almost a century of FDA, if you still don't realize you can't spend your way out of non-compliance as if dealing with FDA was a one-time project, maybe this industry isn't for you.
2. Swift and aggressive enforcement action by the FDA
The old days of multiple warning letters may be gone ... at least for the next few years. FDA leadership is under fire by Congress and the GAO to actual demonstrate its ability to make manufacturers "do the right thing." There's no point in having laws and regulations on the books if the agency is going to treat them as guidelines.
There's little doubt that one of the precursors for this announcement was the whole peanut debacle, plus the steady increase in consent decrees and corporate integrity agreements.
Again, based on my experiences, FDA says one thing but so often company executives hear something else. Sometimes this is an excuse not to do something.
But sometimes, what is heard is impossibly conservative, as in "The FDA says we have to secure our supply chain" being translated into "We need to audit and control every single company in our entire supply chain, from our actual supplier all the way down to the mine in the ground where they originally got the raw minerals that went into their supply chain that eventually found their way into our product." Yes, really - that's a comment from a medical device executive at the recent FDA Supplier Quality Management conference in D.C. Frankly, if we want to know where our high cost of healthcare starts, I'd suggest we clearly spell out that drug and device makers are not responsible for the quality of mineral mining operations and ore smelting....
There is a balance. If you don't understand that balance, or how to derive it, get help before the agency does it for you. The latter is called a consent decree and comes with millions of dollars of financial penalties and lots and lots of bad publicity.
3. Faster warning letter issuance
Thankfully, FDA will stop having its legal department review every formal enforcement action for wordsmithing, and just confine the legal review to actual legal issues. This is something that a LOT of companies could copy. I know I spent years working with a firm where every single SOP and Work Instruction had to be reviewed by the lawyers. You'd send in a simple 3-page SOP and get back a 30-page SOP full of language like "...including, but not limited to..." and "...as deemed appropriate at the time of the decision with information immediately on hand or otherwise apparent..." and so on....
Turning things into legalese doesn't do much to increase people actually complying with them.
4. Timely inspection follow-up
Basically, instead of getting inspected and finding problems, issuing a warning letter, and then showing up 3-4 years later to see how you're getting on, the FDA will now issue a warning letter and show up sometime in the next 6 months to 2 years (depending on risk, criticality of issues, etc.). People outside the industry think that's how it's always been.
Assuming that FDA cannot keep this type of timeline, look for the agency to be able to produce metrics showing Congress that "Hey, if you want this type of swift enforcement, it don't come cheap" and pushing for more funding. What will be interesting to see is how Congress responds. Earlier this year, I suggested levying civil monetary penalties to reimburse the agency for having to do re-inspections, issue warning letters, etc. - something that most consent decrees already have. It's a model based on the "do not call" registry as well. This past summer, members of Congress have started floating a similar idea.
For compliance executives who want to demonstrate bottom line value to their company, there is no easier way than to make a list of previous non-compliance actions that cost XYZ amount of money ... and then put in place controls to prevent those actions.
5. Warning letter closeout process
This has been a long time coming and well needed. Today, FDA just removes the original warning letter from its website, rendering researching previous FDA enforcement actions a spotty, unreliable means of figuring out how to prioritize your compliance.
As I discuss in my FDA enforcement seminar, Bulletproof Yourself against FDA Enforcement, your job is to provide as much information in both record proof and summary form so that you make it easy for FDA to issue you a close out letter. Remember, with shareholders and investors increasingly seeing quality systems and regulatory compliance failures "material information" that you need to disclose publicly, getting a "close out letter" is critical to avoiding investor lawsuits.
6. Increasing collaboration with other regulatory agencies
This is NOT just collaboration with international harmonization partners like members of the ICH or GHTF or Health Canada or the EMEA. This also includes taking a cue from other US agency inspectors like those from OSHA or HHS (ala HIPAA) or SEC, or from state inspectors. If those inspectors turn up issues, you should be expecting a phone call or knock on the door from the FDA shortly thereafter.
FDA harmonization is one of many issues I offer a lot of insight and advice on in my monthly newsletter, SmarterCompliance.
For instance, the FDA is working to knock down many of its barriers to cross-functional and cross-agency communications and coordination. Kim Trautman of CDRH told executives from drug, device and biologic firms to stop seeing the GMPs and QSRs as distinct regulations only applicable to one type of firm or another. And this is on top of last year's announcement that FDA would enforce ICH guidelines (followed promptly by the first warning letters citing ICH rules). There should be little doubt that GHTF guideline enforcement is not far behind especially since FDA has been instrumental in crafting those rules as well. FDA inspectors are being trained to look for your compliance with all of these.
To learn more ...
If you'd like to learn more about how to prepare yourself for stricter FDA enforcement in 2010, consider signing up for my September 29th webinar - Bulletproof Yourself against FDA Enforcement. You can also download the detailed agenda here: http://www.ceruleanllc.com/Webinar/default.htm
Are you ready?
