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FDA Works to Balance Domestic Drug Supply and Market Freedom

October 6, 2011 By Leave a Comment

Patrick Stone, President, TradeStone QA

The balance between cost effectiveness and a safe drug supply may be measured in the amount of poor/under-employed patients not receiving their medication. These individuals may seek their pharmaceuticals online from imported sources thus breaking the law and possibly receiving harmful counterfeit drug products. Counterfeit drugs and placebos, labeled as heart medications, blood pressure medications, diabetes medications, etc., are currently hospitalizing a vulnerable proportion of American citizens.

The FDA does not publicly go after counterfeit drug operations and the Office of Criminal Investigations (OCI) at FDA would be responsible for the interdiction of such criminal activity. There are very few OCI agents in the FDA, so counterfeit drug searches are not conducted Sheriff or Texas Ranger style. If the FDA OCI get a tip about a counterfeit operation they usually go in with Sheriff and FBI/DEA/HS for back up.

FDA public affairs and media relations may not go far enough explaining and describing the extreme dangers of buying health care maintenance drugs from an unapproved imported source.

There are many reputable foreign pharmaceutical companies legally and safely distributing effective imported medications. The FDA is currently focused on tobacco and food products like rural milk production; counterfeit pharmaceuticals appear to be low priority. Many of the counterfeit drug operations take place outside the United States and are imported in through legal or illegal channels.

The FDA Import Division would be the most responsible resource for stopping the flow of harmful drug products. The DEA and DOJ are focused on scheduled narcotics and bulk illegal substances. When the product comes in a pill bottle sold in most drug stores the priority may also be very low.

Health-care customers and marketing business firms need to understand the US regulations for importing health-care products from licensed broker that goes through the FDA/US Customs regulatory oversight. It is always good to verify that the product you purchased matches the description on the package insert.

The US government is trying to balance security and freedom of choice on the razors edge. It may take some time to ensure security at the cost of your advertising freedom. It is always a good idea to ask your doctor or pharmacist about your drug products and how to physically identify your medications.

Patrick Stone is the author of Bubble Gum Badge – An FDA His-Story. You can also follow him on Twitter.

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Filed Under: FDA Regulated, Patrick Stone, Pharma/Biotech, Regulatory Tagged With: , , , ,

Device, Drug Manufacturers Push FDA for Greater Consistency, Standards When it Comes to Good Importer Practices

June 17, 2009 By Leave a Comment
Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

It sounds like most folks think the FDA should be doing more to strengthen the quality and consistency of medical devices and drugs that come into this country. And that includes the folks who make the stuff.

FDA recently unveiled a draft guidance for industry, “Good Importer Practices.”  It was issued in response to recommendations contained in the Action Plan for Import Safety: A Roadmap for Continual Improvement (Action Plan) back in November 2007, by the Interagency Working Group on Import Safety (Working Group) established by Executive Order 13439 (see http://www.importsafety.gov/report/actionplan.pdf).

The Action Plan recommends that the Federal Government work with the importing community and other members of the public to develop Good Importer Practices and issue guidance. The Action Plan specifies that the focus of these practices should be to ensure that imported products meet U.S. standards, as well as to promote effective supply-chain management. The Action Plan recommended that these practices be risk-based and provide concrete guidance to the importing community for evaluating imported products.

That’s all well and good, but there’s a hint of frustration underlying some of the comments from industry.

Quick example, AdvaMed notes, “Device companies have reported that one of the challenges they face in complying with the requirements proposed in the guidance is FDA’s uneven documentation requirements at different ports of entry.” They call on FDA to standardize its documentation requests at such ports.

AdvaMed, and other commenters, also call the FDA out to be more specific in some of its terms. Reminiscent of the way 21 CFR Part 11 was at first interpreted way too broadly and served to stymie the technology it had meant to promote, commenters here want the FDA to be very clear when using terms like “appropriate steps,” without spelling out what those are.

Pfizer wants the FDA to be tougher. It also calls on the agency to establish a voluntary certification program for “highly compliant importers.” Those that agree to a higher bar would also get faster review status from the FDA because they were identified as “trusted importers.” That’s not a bad idea and reminds me a bit of how some folks who are pre-screened at airports get to move through the line faster.

PhRMA calls for clarity, too. They also want to see a concise executive summary and a glossary – just so we all know we’re talking about the same thing here.

They also raise an interesting point: “The draft guidance contains expectations about the risks and compliance history of firms which manufacture, distribute or transport products and also proposes that websites of all relevant regulatory authorities be checked for information on non-compliance…much of the information sought in this provision is simply not publicly available.”

To view the latest comments, go to:
http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=FDA-2009-D-0675

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Filed Under: FDA Regulated, Michael Causey, Regulatory Tagged With: , ,

FDA Importer Guidance for Medical Devices: What it Means to you Going Forward

March 17, 2009 By 2 Comments

intensive care unit monitorThe FDA has had many challenges and setbacks in the past few years. From budget cuts to high-level departures, the agency has also faced fury from lawmakers on Capitol Hill over high-profile device, drug and food recalls.

Off the record, current and former FDAers have told us that they know they’ve been understaffed and underfunded in recent years, and that their enforcement capabilities often weren’t up to the task.

Now with a new president and renewed focus on government regulation in Washington, it’s likely pressure from the White House and Capitol Hill will spur the agency to be more active this year and in the next several years, experts say.

In a new white paper from AssurX, you’ll learn why a FDA’s new Good Importer Practices draft guidance is putting the device industry on notice. The white paper explains that the FDA will:

  • Hold those at the top accountable for any import problems for their
    products,
  • Expect medical device manufacturers to be vigilant about quality, and;
  • Increase its emphasis on device firms’ catching and correcting mistakes and
  • complaints.

As this new guidance demonstrates, a revitalized FDA today demands that medical device manufacturers to build quality into their products from the very beginning, and to spot procedural problems very early in the product lifecycle.

At its heart, the FDA guidance wants device manufacturers to:

1) Establish procedures for developing corrective action plans, and for taking corrective and preventive actions if non-compliance with a U.S. requirement or a safety concern should arise.

2) Identify and investigate the root cause of non-compliance with U.S. requirements for products they import, or by foreign firms with which they do business.

3) Take steps to remediate and prevent harm from present and future shipments, and to ensure non-compliance and safety problems do not recur.

4) Work with the non-compliant firm to meet U.S. requirements, or stop conducting business with that firm.

“This is part of a broader effort, pushing responsibility for manufacturing on the manufacturer,” says Mark Mansour, an attorney with Bryan Cave LLP in D.C. While the FDA is saying it will inspect and enforce more, manufacturers are counted on as the “first line of defense,” he adds. “Device firms should take this very seriously,” Mansour said.

Request your copy of the FDA Importer Guidance for Medical Devices paper here.

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Filed Under: FDA Regulated, Featured, Medical Devices, Quality Management, Tamar June Tagged With: , , , ,