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FDA to Industry: Contractors R U

It seems a rather uncontroversial proposition: FDA-regulated companies are responsible for their vendors, including every contracted piece of work that is done on the company’s behalf. If problems develop, it makes no difference whether a company did it…or a contractor did it for them. Two seemingly unrelated items this week suggest that FDA is becoming concerned about whether FDA-regulated companies are overseeing their vendors.

This is not just about contract manufacturing. FDA’s concerns extend to company/contractor relationships in marketing, distribution, communications, clinical trials, pre-clinical development, etc. FDA Matters expects food and device companies to be under similar pressure to improve their oversight of vendors, since the concerns about contractor reliability should be similar.

Beyond the well-publicized quality control problems at some major companies, FDA may foresee industry-vendor relationships as a more general concern. Perhaps FDA sees controls on the burgeoning responsibilities of contractors (out-sourcing) as a natural extension of the agency’s regulatory responsibilities. FDA may also be signaling to industry that it will do them no good to whine: our contractors let us down and, therefore, the company shouldn’t be held accountable.

New rules for outsourcing drug manufacturing. The Wall Street Journal reported on a conference in Ohio at which FDA officials said they will propose strict regulations for companies that outsource drug manufacturing. The goal is to hold sponsor companies more accountable for their vendors, whether in the US or abroad. In the past three years, violations of good manufacturing practices (GMPs) have increased threefold for contractors, while remaining stable for sponsors.

Despite what some might consider an unwelcome extension of regulatory controls, the items discussed by FDA are fairly benign. It even seems a little odd that FDA does not already require them. Specifically, the FDA will propose rules that include:

  • FDA warnings about manufacturing violations will go to both the contractor and the sponsor, not just the contractor,
  • sponsors will be required to conduct on-site audits at contract manufacturing facilities to ensure the quality of production and the safety and purity of ingredients, rather than allowing sponsors to rely on off-site review of records and reports compiled by the contractor.

New standards for evaluating clinical trial protocols. Dickinson’s FDA Webview covered an FDA presentation at the Drug Information Association meetings in DC about changes in the agency’s oversight of clinical trial design and implementation. Company protocols will need to be accompanied by information about how the study incorporates “quality by design” (i.e. companies must plan quality into the project rather than assume it happens as a byproduct of earnest effort).

Henceforth, the agency will consider the “operational merit” of a proposed protocol in additional to the traditional review of “scientific merit.” On a practical level, this means that FDA will want to know why the study will have 60 sites instead of 30, why sites were chosen, how investigators were selected, who’s monitoring sites and how investigators will be trained.

FDA presented this in the context of clinical trial results that can be relied upon…..but it relates directly to an activity primarily done by company contractors, whether a contract research organization (CRO) or academic researchers.

However much the latter example (clinical trials) appears to differ from the former example (drug manufacturing), the principles are essentially the same. FDA is telling companies: you are responsible for your vendors and we want evidence that you are watching them much more closely than you have in the past.

No company can be stronger than its weakest vendors. FDA-regulated companies should start now to evaluate their contractors, then extend and strengthen their everyday oversight.


Wall Street Journal article: “FDA to Propose Tougher Rules for Outsourcing Drug Manufacturing,” appeared on June 15, 2010. http://online.wsj.com/article/SB10001424052748704324304575307421660792654.html#articleTabs%3Darticle

Dickinson’s FDA Webview, www.fdaweb.com, “Clinical Studies Will Need More Design Details: FDA,” June 14, 2010 (by subscription or individual articles may be purchased) http://www.fdaweb.com/login.php?sa=v&aid=D5115187&cate=&stid=%241%24Wl1.n52.%24zGTEH.bvqbwrCcWcM%2FA3k .

Quality Control Woes: What’s a CEO to Do?

June 2nd, 2010

Medical products companies are struggling to assure FDA and the American people that their products are “safe as manufactured and distributed.” We don’t know whether quality control has become lax, FDA is discovering more problems or industry has just had a run of bad luck. We do know that quality control relies on a lot of people maintaining tough standards…and that manufacturing is rarely a priority of a drug and device company CEO. Earlier this year, in the wake of Toyota’s problems, FDA Matters asked: “what’s a CEO to do?” Read the rest of this entry »

One Response to “FDA to Industry: Contractors R U”

  1. The New York Times has a news story about oversight of foreign clinical trials. Again, it is evidence that the DHHS IG (with FDA agreeing) believes that drug companies are not overseeing their vendors (the overseas clinical trial sites). Running clinical trial sites (US and ex-US) is a business and company to trial site is a business relationship.

    HHS Report Incites Concern Over Foreign Drug Trials.
    The New York Times (6/22, A14, Harris) reports that “Daniel R. Levinson, the inspector general of the Department of Health and Human Services,” will release a report on Tuesday that found “80 percent of the drugs approved for sale in 2008 had trials in foreign countries, and 78 percent of all subjects who participated in clinical trials were enrolled at foreign sites.” But Levinson “pointed out that the [FDA] was often unaware of foreign clinical trials as they were being conducted. As a result, federal regulators have no ability to ensure that patients in these trials are being protected while the research is continuing.” Rep. Rosa DeLauro (D-CT) said, “By pursuing clinical trials in foreign countries with lower standards and where F.D.A. lacks oversight, the industry is seeking the path of least resistance toward lower costs and higher profits to the detriment of public health.” The Times also notes that “the F.D.A. was unable to provide Mr. Levinson’s investigators with detailed clinical trial data for 29 of the 129 of the approved applications in 2008.”

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