The Federal Trade Commission's first-of-its-kind lawsuit alleging abuse of the U.S. Food and Drug Administration's citizen petition process will shed light on when drugmaker efforts to delay generic competition cross a blurry line between free speech and obstruction, experts say. The lawsuit was filed in response to efforts by Shire PLC unit ViroPharma to delay generic versions of Vancocin, its brand-name antibiotic. In recent years there were 46 public filings, including 24 citizen petitions, lodged by the company.

In the hopes of curbing underhanded petitions, Congress in 2007 amended federal law that authorized the FDA to flatly reject petitions that clearly don't raise legitimate issues. It also directed that the FDA not delay generics unless public health would be jeopardized.

In response to the volume of ViroPharma's filings, which the FTC called "repetitive, serial and meritless," there is debate as to when a citizen petition becomes a sham petition.

Leslie E. John, antitrust leader at Ballard Spahr LLP, noted that nearly 20 of the 46 filings were public comments submitted by ViroPharma, as opposed to full-fledged petitions, and therefore perhaps less than meets the eye.

"Some of them are simply follow-on filings, so I don't know that you can make the argument that simply because there are a lot of filings, that necessarily delayed FDA, and that necessarily is something that warrants special scrutiny on the part of the FTC," John said.

The FDA issued an 87-page response to ViroPharma's petitions in 2012, which is a very lengthy response for citizen petitions. That long response could suggest that the FDA didn't find ViroPharma's assertions about essential generic-drug testing to be blatantly invalid.

"There's a tension in the FTC's arguments, because ... the FTC says that all of the petitions are baseless and unsupported by any scientific evidence," John said. "If that were true, one would think that FDA could have readily dismissed them."

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