As yet another small, one-product medical device company goes belly-up and complains of a lack of transparency at FDA, it seems that the agency’s internally directed and once-ballyhooed transparency initiative has been an overall failure.

Jim Dickinson

December 27, 2010

11 Min Read
Six Steps to Fix FDA


Acorn Cardiovascular and Disc Dynamics added their tombstones to the graveyard in December, barely a month after embattled TMJ Implants was sold off in bankruptcy court. Each has complained about FDA’s lack of transparency and predictability as the principal causes of their demise. As a result, it seems time to propose a simple, six-step, externally directed plan to reopen the agency and make it more transparent again, much as it was prior to 1996 but with modern technological enhancements. Being mindful that companies and news media are as wary of each other as government agencies and news media are, I present it below:

  1. Under presidential directive, accept the premise that everything FDA does is to benefit the public, and that the public at large is to define the meaning of its benefit in this context.

  2. Using an external federal scientific agency organizationally unrelated to FDA, reach out to the public through all media to learn their expectations of FDA.

  3. Establish an open public process to examine and adopt all inputs received from the public as to their expectations.

  4. Within existing statutes, open all FDA processes and records to lawful public access as required by the published results of (3) above.

  5. Where laws and regulation impede public access, submit all of these situations to a public review process and submit the findings to town hall meetings of interested constituencies around the country.

  6. Submit resulting recommendations to the public and to Congress.


I acknowledge that there may not be enough opportunities for creative lawyering in this proposal, and consequently the concept may be dismissed as too naïve. But it has the virtues of simplicity, being external to the secret-makers inside FDA, and empowering a public that is increasingly alienated by government. Alternately, we can keep the status quo until FDA’s next public health disaster compels a different approach, or another couple dozen device companies go belly-up.


The importance of transparency in any government agency may be seen in a startlingly credible op-ed published in October in the Los Angeles Times, written by FBI whistleblower Coleen Rowley and FAA whistleblower Bogdan Dzakovic. They hypothesize that 9/11 could have been prevented if Wikileaks had existed then, since ample prior warning by FBI agents was repeatedly ignored and actively suppressed by their superiors in Washington, creating sufficient frustration to go public without revealing one’s identity, á la Wikileaks.


There is much merit to their suggestion and it applies as well to the suffocated constitutional role of a free press that is supposed to “trust but verify”—to borrow Ronald Reagan’s famous maxim—legally unprotected government activities that are now shielded by a virtual iron curtain separating us from our government. This virtual iron curtain sprang up in the wake of the 1996 Oklahoma City bombing when federal employees had to be physically protected under new security measures in all federal buildings. The measures greatly intensified after 9/11, evicting free-range news media and choking off their access except through the bureaucratic bottlenecks of politically manipulative press offices.


“Trust but verify,” using time-honored confidential inside sources, gradually became impossible and at the same time, many in the agency began developing an arrogant sense of unaccountability. No need to explain why we won’t tell you this—our way or the highway! Secrecy for secrecy’s sake became the rule.


It is important to recognize here that I am not advocating lifting the legal veil off of lawful secrets that FDA must by statute protect—just the myriad unlawful ones that it has informally established for its own internal comfort and convenience. The issue is not the comfort levels of agency employees, who would rather not be approached by companies seeking help or by reporters asking about their work or opinions. Rather, it is about whether more openness, albeit on a confidential basis, could prevent another health product disaster like thalidomide, the Medtronic Fidelis lead, or contaminated heparin from China—or prevent more small companies from foundering needlessly.


As Rowley and Dzakovic write about it, the FBI experience before 9/11 was chillingly like FDA’s experience recently, right down to warnings against talking to the media: lower-level employees being silenced by upper-level employees when they had something disturbing or non-PC to say. In different ways, Wikileaks and a functioning investigative news media each mitigate against such suppression of conscience and First Amendment rights by at least providing a public focus on whether every perceived "secret” really needs to be a secret under the law.


Shuren Dismisses ‘Flawed’ Study on Device Delays


CDRH director Jeffrey Shuren has dismissed a recent study on device approval delays, calling it “highly flawed” due to its inadequate sample size and conclusions. It was conducted by Stanford University consulting professor of medicine and medical device entrepreneur Josh Makower.  The study, which was supported by the Medical Device Manufacturers Association (MDMA) and the National Venture Capital Association, said that delays in medical device approvals created by FDA regulatory hurdles “are costly to patients desperate for new treatments and to small, innovative companies that often don’t have the resources to withstand regulatory uncertainty.”


Shuren’s remarks were made to Mass Device, an online newsletter tracking Massachusetts’ medical device industry, after he provided an update to the Massachusetts Medical Device Industry Council (known as MassMEDIC). He said the response rate of firms surveyed was too small, pointing out that lower response rates would magnify the opinions of people unsatisfied with the process.


Shuren particularly took issue with the study’s conclusion that the majority of costs to bring a device to market were spent satisfying FDA requirements. “It takes $31 million to bring a lower-risk device to market, $24 million of which is spent on FDA-dependent or related activities,” Makower said. “For higher-risk products, the tab is even steeper—$94 million, with $75 million spent on stages linked to FDA. As a result, researchers and medical device firms are increasingly considering leaving the United States and setting up shop abroad, taking valuable jobs and tax revenue with them.”


“The cost issue was based on the first time the company talked to FDA through the time it went to market,” Shuren said. “But, we talk to companies when the product is under development, which you don’t get in the European Union. We got dinged for talking to companies early...We could cut costs dramatically by not talking to companies early, but I don’t think anyone wants that,” he said. “It’s a horrible survey.”


Some critics scorn Shuren’s statements, saying that Shuren doesn’t truly understand the situation in part because he is like prior bureaucratic CDRH directors who rely on and support the advice provided by incompetent subordinates.
And what about support from device trade associations such as MDMA and AdvaMed? Some industry critics say that they supported or did not object to user fees, which then led to more unnecessary fees for registration and other elements that have not produced any measurable benefit for the public. In other words, it could be said that these groups share the responsibility for the failure of the device regulatory system.


AdvaMed Praises Shuren on 510(k) Changes


Washington, D.C.–based trade associations that are dependent on good relationships with FDA personnel for their continuity seem to step gingerly around the agency’s pathological lack of transparency and its impact on companies too small to pay sales-based membership dues. Theirs is a world of well-oiled connections.


So it wasn’t surprising in December to read AdvaMed president Stephen Ubl’s warm words for statements reportedly made by CDRH director Jeffrey Shuren at a MassMEDIC event. In these comments, Shuren recognized the need to improve the center’s effectiveness in supporting innovation and making a commitment for an interactive premarket review process that is “predictable, consistent, transparent, and timely.”


“His remarks reflect support for commonsense 510(k) reform recommendations that will address some of the most critical problems at the center—recommendations for enhanced guidance and standard operating procedures, greater transparency and clarification of review requirements, and increased training for center staff and industry,” Ubl said, without seeming to recognize that “transparency” has so far been only an empty buzzword for FDA.


“As the reform process moves forward, we look forward to continuing to work cooperatively with Dr. Shuren and his staff,” Ubl continued. “There are a number of areas where broad support for needed changes exists. These points of agreement should serve as a foundation for future reform efforts. Such an approach would improve the 510(k) process and would avoid proposals that could have a negative impact on innovation and patients.”


No doubt these cooperative efforts will continue to be pursued behind closed doors, in the time-honored way.


CDRH Completes 86% of Strategic Priority Actions


CDRH says that it accomplished 92 of the 107 actions (86%) in FY 2010 that it wanted to complete as part of its strategic plan, just over its goal of 85%.


The center had previously identified 123 actions to be taken in its list of FY 2010 strategic priorities, with 107 of them to be completed within the fiscal year. Among the accomplishments it claims are the following:

  • Completed and released for public comment two preliminary reports recommending concrete steps that could be taken to strengthen the 510(k) program and increase predictability of use of science in regulatory decision making by fostering medical device innovation, enhancing regulatory predictability, and improving patient safety.

  • Launched the CDRH transparency Web site.

  • Implemented the CDRH leadership program.

  • Established and held a public meeting of the Council of Medical Device Innovation.


FDA: BioCheck Marketing Products for Unapproved Use


An FDA inspection last summer at BioCheck’s in vitro diagnostic (IVD) device manufacturing facility in Foster City, CA, found that the firm also manufactures in vitro reagents identified for research and investigational uses that have not been approved by FDA. A December 7 warning letter from FDA’s San Francisco district office says that a review of promotional materials and labeling found several statements for which FDA approval is required.


Some of the firm’s responses to the inspectional observations were adequate, the letter said, but others were not. The district office acknowledged BioCheck’s voluntary recall of its Human Cardiac Specific Fatty Acid–Binding Protein Enzyme Immunoassay Test Kit and removal of the diagnostic claims. However, it said, corrective action was incomplete for the firm’s Prostate Specific Antigen Enzyme Immunoassay Test Kit, Carcinoembryonic Antigen Enzyme Immunoassay Test Kit, and Rubella IgG Enzyme Immunoassay Test Kit because they are still being distributed with unapproved diagnostic claims and remain in commercial distribution.


The letter said the agency wants the company to immediately stop marketing, promoting, and distributing all IVD products that require premarket approval or 510(k) clearance and don’t have such approval or clearance.


BioCheck also was told to respond within 15 days with a list of specific steps taken to correct the violations and prevent their recurrence, along with documentation of the steps and a timetable for completion. In addition, the firm was asked to indicate what it planned to do with existing stock and products in the field that had been previously shipped, for which the company does not have marketing approval.


Quality Problems Found at Steris Isomedix Facility


An FDA inspection last June at Steris Isomedix’s contract medical device sterilization facility in Grand Prairie, TX, found quality system violations, according to a September 27 warning letter from FDA’s Dallas district office. The letter, released in December, details specific violations that include the following:

  • Failure to establish procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria.

  • Failure to establish adequate procedures to control product that does not conform to specified requirements.

  • Failure to establish and maintain adequate procedures for implementing corrective and preventive action to correct and prevent recurrence of quality problems.

  • Failure to validate manufacturing processes whose results cannot be fully verified by subsequent inspection and test with a high degree of assurance and approved according to established procedures.

  • Failure to maintain device history records for each batch, lot, or unit to demonstrate that the device is manufactured in accordance with the device master record.


The letter said that some of the firm’s responses to the observations were inadequate. Steris was told to take prompt action to correct the violations and prevent their recurrence. The company was to submit a list of actions taken or planned, with documentation and a timetable for completion.


CGMP Problems Found in Cranial Plate Implant Manufacture


An FDA inspection at OsteoSymbionics’ cranial plate implant manufacturing facility in Cleveland in October found current good manufacturing practice (CGMP) violations, according to a November 30 warning letter from FDA’s Cincinnati district office. Specific violations included the following:

  • Failure to establish and maintain procedures to control device design to ensure that specified design requirements are met.

  • Failure to establish procedures and to validate a process whose results cannot be fully verified by subsequent inspection and test.

  • Failure to establish corrective and preventive action procedures that include requirements for analyzing processes, quality records, and work operations to identify existing and potential causes of nonconforming product or other quality problems.

  • Failure to implement procedures for identifying, documenting, validating, or, where appropriate, verifying, reviewing, and approving all design changes before their implementation.

  • Failure to maintain a device master record for the cranial plate implants.


The company was told to take prompt action to correct the violations and to submit a list of steps taken with documentation and a timetable for completion.

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