Boston Scientific Resolves Warning Letter Issues

The pall has finally been lifted.

After more than four years, Natick, Mass.-based Boston Scientific Corp. has resolved regulatory issues cited in a U.S. Food and Drug Administration (FDA) warning letter, clearing the cloud of perceived misgivings from the agency that has hovered over the company longer than expected.

The January 2006 warning letter cited “serious deficiencies” at several Boston Scientific facilities throughout the nation, including the Maple Grove, Minn., headquarters of its $1.7 billion drug-coated heart stent business. One of the deficiencies cited by the FDA was a failure to promptly and properly report product issues, according to published reports. The letter followed three site-specific warnings in 2005 that Boston Scientific failed to adequately address.

Though they typically are used to force companies to comply with FDA regulations, corporate-wide letters such as the one received by Boston Scientific are relatively rare. When it issued the letter, the FDA gave the company an ultimatum: Fix the regulatory issues or the agency would block approval of all Class III products (which usually are the most novel and highest-risk devices the FDA evaluates).

The FDA made good on its threat, too. For two years, the Class III product approval ban remained in place, delaying the release of Boston Scientific’s much-anticipated Taxus Liberte medicated heart stent. By the time Taxus was approved, the domestic market for stents had become more crowded and competitive.

In late 2008, the company showed improved quality systems during an inspection of its facilities, prompting the FDA to note that Boston Scientific was in “substantial compliance” with the agency’s regulations. Since that time, the warning letter has not been an issue, though it still cast a dark cloud of doubt over the company until the letter was officially resolved earlier this month.

“The resolution of the corporate warning letter marks a major milestone in our journey of continuous quality improvement,” Ray Elliott, Boston Scientific’s president and CEO, said in a statement. “Quality is our highest priority and our greatest responsibility. While our quality work will never be done, we have revolutionized our approach and transformed our culture, and we are confident that our commitment to the highest levels of quality will create a competitive advantage for Boston Scientific.”

Resolving problems cited in warning letters can be time-consuming and expensive for companies. Stryker Corp., for example, is still revamping its quality and compliance programs three years after receiving a string of warning letters from the FDA. The Kalamazoo, Mich.-based orthopedic manufacturer resolved the final warning letter in May.