Lost amid the presidential campaign, the sour economy and other sobering distractions over the past few months, the advent of follow-on biologics continues to lurk in the background as a significant issue that can be expected to regain attention sooner than later.

Biologics, of course, are expensive - costing tens of thousands of dollars and up annually. But there is no approved regulatory framework allowing biotechs to develop and market follow-ons, although three bills are lingering in Washington. A Congressional Budget Office report found the cost of a Senate bill, if enacted, would reduce total expenditures on biologics by $25 billion between 2009 and 2018.

Now, the Federal Trade Commission is examining the issue with an eye toward sorting out competition, incentives and patents. The FTC, remember, has been laboring to derail so-called pay-to-delay deals between brand-name drugmakers and generic rivals. So the agency plans to hold workshops to figure out ways “to strike the right balance between regulatory exclusivity periods and competition to spur development” of follow-on biologics.

The FTC is seeking comments on 18 questions divided into two groups. One set deals with regulatory exclusivity, competition and “whether, or to what extent…regulatory incentives should be adopted in creating a pathway.” The second focuses on resolving patent disputes and asks, among other things, about lessons learned from the Hatch-Waxman Act and resolving patent disputes. For more, read the Federal Register notice.

Where is the FTC headed? As the FDA Law blog reminds us, the FTC wrote a letter in May to the House Energy & Commerce Committee, saying Congress “should limit companies’ ability to game…exclusivities at the expense of consumers by (1) disconnecting the FDA approval process for generic biologics from patent litigation, and (2) ensuring there is no opportunity for brands effectively to lengthen their exclusivities through insignificant changes to a branded biologic product or through excessive procedural delays.”

Should be fun.

Hat tip to the FDA Law blog