A Medical Device Daily
The latest warning letter to a division of Stryker (Kalamazoo, Michigan) highlights one of the dilemmas facing all drug and device firms that hire sales forces. On the other hand, it also was the third letter to the firm since January 2007, and called into question the company's overall compliance work, especially in light of findings that its products have been contaminated with bacteria (Medical Device Daily, Jan. 18, 2008).
The April 25 letter to Stryker Biotech (Hopkinton, Massachusetts) states, "FDA is aware of falsified IRB (institutional review board) documentation submitted by some of the sales force prior to the initiation of the inspection." FDA went into no detail on this citation.
The first citation states that Stryker "failed to obtain an investigational device exemption (IDE) prior to initiating a clinical investigation of the OP-1 implant." OP-1 is a sterile powder containing recombinant human bone morphogenetic protein that is currently available only under the Humanitarian Device Exemption. Given that some of the OP-1 powder was distributed, FDA also cited Stryker for distribution without a PMA.
In a May 2 press statement, Stephen MacMillan, president/CEO of Stryker, said the company "take[s] this matter very seriously, will continue to cooperate fully with FDA, and have initiated significant measures to address FDA's concerns." This is said to include both corrective actions at Stryker Biotech a company-wide quality action plan for all divisions and plants.
The company recently pledged to invest $50 million this year to get quality control and regulatory compliance operations up to speed. MacMillan is quoted as having said at the company's annual meeting earlier this month, "I feel better today than I did 90 days ago," about the company's compliance problems. He took the position that regulatory scrutiny is more intense than in times gone by.
Patent rulings may be invalidated
A professor of constitutional law has stumbled upon a piece of legislative arcana that may invalidate the appointment of dozens of judges who hear patent cases, potentially invalidating every decision those judges made going back to March 2000.
John Duffy, who teaches law at the George Washington University Law School (Washington), discovered that a law written into the books in 1999 ran afoul of other, superseding constitutional provisions. The 1999 law put the power of appointing administrative patent judges in the hands of the director of the U.S. Patent and Trademark Office. However, Duffy makes the case that the Constitution allows only department heads to make such appointments and because PTO is a division of the Department of Commerce, the PTO chief is not empowered to make those appointments.
If Duffy's view of the situation prevails, the decisions of 46 of the 74 judges now handling patent cases may be legally invalidated. The first case is likely to be for Translogic Technology (Apex, North Carolina), which has requested a hearing by the Supreme Court. As yet, the Court has not decided whether to hear the case, but lower courts presided over by the affected judges now face the dilemma of whether to proceed with patent cases. In October, Translogic lost its $86 million suit against Renesas Technology (Tokyo) for infringement of a design for microprocessors designed as microcontrollers.
There seems to be little dispute in Duffy's interpretation. John McGinnis, a law professor at Northwestern University School of Law (Chicago), who was at the Office of Legal Counsel (OLC) at the Department of Justice at the time of the law's passage, said Duffy's analysis looks pretty tight.
McGinnis is quoted as having said "you have to understand that OLC look at just an enormous number of bills. A line attorney just might miss it."
FDA still relying on firms for translators
Operators of diagnostic X-ray equipment have to undergo FDA inspections just like the manufacturers, and FDA published a guidance last week on its updated field inspection program. The document reads as much like a field manual for FDA personnel as it does like a document for industry's use, but also implicitly puts the burden of providing a translator on any foreign firms that are under inspection.
The guidance says that FDA "will be phasing out calibration services currently provided for a number of instruments in the field," but will identify "alternate sources of equipment calibration." The guidance also states that foreign firms that will be inspected should be notified of inspections as early as possible to allow the firm to "make arrangements to have a translator available if needed." FDA has sought help from the Department of State to provide translators who are independent of the firm undergoing inspection (Medical Device Daily, Jan. 31, 2008), apparently still to no avail.