Senators Introduce Access to Affordable Medicines Act to Close Labeling Change “Loophole”; Companion Bill to Senate Drug Price Competition Act of 2009 Introduced in House

October 15, 2009

By Kurt R. Karst –      

On October 14, 2009, Sens. Jeanne Shaheen (D-NH) and David Vitter (R-LA) announced the introduction of S. 1778, the Access to Affordable Medicines Act.  The bill would amend the FDC Act’s ANDA provisions at § 505(j) to add a new subsection stating that:

If the proposed labeling of a drug that is the subject of an application under this subsection is different from the labeling of the listed drug at the time the Secretary evaluates the application under this subsection, the drug that is the subject of such application shall, notwithstanding any other provision of this Act, be eligible for approval and shall not be considered misbranded under section 502 if –  

(A) a revision to the labeling of the listed drug has been approved by the Secretary within 60 days of the expiration of the patent or exclusivity period that otherwise prohibited the approval of the drug under this subsection;

(B) the Secretary has not determined the applicable text of the labeling for the drug that is the subject the application under this subsection at the time of expiration of such patent or exclusivity period;

(C) the labeling revision described under subparagraph (A) does not include a change to the ‘Warnings’ section of the labeling;

(D) the Secretary does not deem that the continued presence in commerce of the labeling of the listed drug (as in effect before the revision described under subparagraph (A)) adversely impacts the safe use of the drug;

(E) the sponsor of the application under this subsection agrees to submit revised labeling of the drug that is the subject of such application not later than 60 days after the notification of any changes to such labeling required by the Secretary; and

(F) such application otherwise meets the applicable requirements for approval under this subsection.

The bill, dubbed the “Generic Loophole Bill,” is intended to “increase access to lower cost generic drugs by closing a loophole some brand name drug companies exploit that needlessly and unfairly delays the entry of safe, lower-cost generic drugs to the consumer market,” according to Sen. Shaheen.  Specifically, Sen. Shaheen commented that:

As the law currently stands, when brand name manufacturers make labeling changes, generic drug labeling must reflect this change prior to the drug being approved and introduced in the market. . . .  [L]ast minute [labeling] changes are often used by brand name pharmaceutical companies to purposefully delay the introduction of cost-saving generic drugs by weeks or months. . . . .  My bill would stop these costly practices by providing a 60-day grace period for the generic drug company to submit the new labeling for approval and marketplace distribution, while preserving safeguards if the new labeling truly presents a safety issue.

It appears that a recent change to the labeling of CASODEX (bicalutamide) Tablets led the Senators to introduce the bill.  According to Sen. Shaheen, “consumer access to the generic version of this drug was delayed by more than 3 months due to a last minute pediatric labeling change . . . .” 

Meanwhile, in the House of Representatives, Rep. Alcee Hastings (D-FL) has introduced H.R. 3777, the Drug Price Competition Act of 2009.  This is a companion bill to S. 1315, which was introduced in the Senate earlier this year by Sen. Bill Nelson (D-FL).  As we previously reported, the bill would amend the definition of “first applicant” at FDC Act § 505(j)(5)(B)(iv)(II)(bb) with respect to 180-day exclusivity eligibility so that certain subsequent ANDA applicants could trigger exclusivity.

Upon introducing H.R. 3777, Rep. Hastings commented that the bill would “help achieve some of the goals that are essential to health care reform: ensuring fair market competition and increasing access to affordable drugs.”  In particular, Rep. Hastings commented that the bill:

allows generic companies that win patent challenges to share the 180-day exclusivity period with the generic companies that first submitted an application to the FDA.  However, no subsequent challenger would be eligible to share in the exclusivity reward once the generic drug has been launched.

If enacted, first-to-file generic manufactures would be less likely to accept a late entry date because this would mean that another generic manufacturer could win a patent challenge and share the 180-day exclusivity period.

The amendments proposed in the Drug Price Competition Act of 2009 appear to be consistent with a paper Apotex, Inc. issued earlier this year.  In that paper, Apotex recommends that Congress work for legislation “that gives shared (if not sole) exclusivity to a generic challenger who, although not first to file a paragraph iv certification, is first to succeed in addressing the listed patents.”

The Access to Affordable Medicines Act and Drug Price Competition Act are just two pieces of legislation Congress is considering with the backdrop of health care reform that could affect the generic drug industry.  On October 15th, the Senate Judiciary Committee held an Executive Business Session to discuss, among other things, a substitute amendment to S. 369, the Preserve Access to Affordable Generics Act, concerning so-called “reverse payment” settlements.  The amendment passed by a 12-7 vote with minor revisions.  (Another amendment proposed by Sen. Tom Coburn (R-OK) that would have changed the evidentiary standard in the Kohl substitute amendment when considering settlements was withdrawn).  Federal Trade Commission Chairman Jon Leibowitz commended the Judiciary Committee on its passage of the bill.  Also, as we previously reported, Sen. John Cornyn (R-TX) is pushing for legislation that would preempt tort suits against generic drug makers.

Categories: Hatch-Waxman