Sen. Casey Takes Over the Reins for the Creating Hope Act; New Bill Substantially Mirrors Sen. Brownback’s 2010 Version

By Kurt R. Karst –      

Last week, Senator Robert Casey (D-PA), along with co-sponsors Sens. Scott Brown (R-MA), Sherrod Brown (D-OH), Al Franken (D-MN), and Johnny Isakson (R-GA), formally introduced S. 606, the Creating Hope Act of 2011.  The bill, which, according to Sen. Casey “has broad support among the medical community, patient advocates and biopharmaceutical companies,” such as the Pablove Foundation, Kids v Cancer, and the National Organization for Rare Disorders, “would strengthen a cost-neutral FDA program giving biopharmaceutical companies an incentive to develop treatments for rare diseases that are often less profitable than treatments for more common medical conditions.”  Specifically, the bill  would amend FDC Act § 524 to change the transferable Priority Review Voucher (“PRV”) program created by the 2007 FDA Amendments Act (the so-called “treat and trade” program), and would amend the PRV program to extend it to applications for a “rare pediatric disease.”

The Creating Hope Act of 2011 is substantially similar to the 2010 version of the bill, S. 3697, which was introduced by now-retired Sen. Sam Brownback (R-KS) and was co-sponsored by Sens. Sherrod Brown (D-OH) and Al Franken (D-MN).  We previously reported on the Creating Hope Act of 2010 here, and we refer you to that post for a summary of the bill. 

Although the 2011 version of the Creating Hope Act makes some minor revisions to the 2010 version, the most important change appears to be the conditions under which FDA may refuse to issue a PRV upon the approval of a rare pediatric disease product application – the so-called “good faith intent to market determination.”  Under both the 2010 and 2011 bills, FDA may consider several factors in determining whether to refuse to issue a PRV, including “the history of such sponsor of producing rare pediatric disease products for which such sponsor received a [PRV], orphan drugs for which the sponsor received exclusivity under [FDC Act § 527], or pediatric drugs for which the sponsor received an additional 6 months of exclusivity under [FDC act § 505A].”  (Neither version of the bill takes into account the new pediatric exclusivity provisions for biological products under new PHS Act § 351(m).)  Added to the 2011 version of the bill is the requirement that FDA issue guidance before making a good faith intent to market determination.  Specifically, the bill states that “[i]f the Secretary requires sponsors seeking a [PRV] to demonstrate a good faith intent to market the rare pediatric disease product in the United States, the Secretary shall first issue a guidance document setting forth the required evidentiary support necessary to demonstrate such a good faith intent.”

The Creating Hope Act of 2011 is one of several bills that will likely be introduced in the 112th Congress that is intended to incentivize the development of new products.  In a few weeks, Representative Phil Gingrey (R-GA), who is a member of the Rare Disease Caucus, will reportedly reintroduce the Generating Antibiotic Incentives Now Act (“the GAIN Act”).  The last iteration of the GAIN Act – H.R. 6331 – was introduced in 2010 and proposed to extend by five years the exclusivity period for a drug or biological product that is a qualified infectious disease product.