Safeguarding America’s Pharmaceuticals Act of 2013 – a bill to improve the integrity of the pharmaceutical distribution supply chain
May 9, 2013
A bill to amend the Federal Food, Drug and Cosmetic Act to secure the pharmaceutical distribution supply chain and improve patient protections by establishing uniform national drug serialization and tracing standards.
Bob LattaRep. Bob Latta (R-OH)
California Congressional Delegation Co-SponsorsRep. David Valadao (R)
- June 17, 2013 — Holt, D-N.J., House speech: Supports the bill. Congressional Record p. E883
- June 4, 2013 — Owens, D-N.Y., House speech: Discusses the bill. Congressional Record p. E796
- June 4, 2013 — Cummings, D-Md., House speech: Discusses the bill. Congressional Record p. E784
- June 4, 2013 — Received in the Senate and referred to the Senate Health, Education, Labor and Pensions Committee. Congressional Record p. S3952
- June 3, 2013 — Measure, as amended, passed in the House by voice vote, under suspension of the rules (two-thirds vote required). Congressional Record p. H2984
- June 3, 2013 — Latta, R-Ohio, motion to suspend the rules and pass the bill as amended, agreed to by voice vote. Congressional Record p. H2968-H2984
- June 3, 2013 — Reported to the House amended by the House Energy and Commerce Committee and placed on the Union Calendar. H Rept 113-93Congressional Record p. H3014
- June 3, 2013 — Additional cosponsor(s): 3
- Veasey, (D-Texas) Walberg, (R-Mich.) Walorski, (R-Ind.)
- May 23, 2013 — Additional cosponsor(s): 1
- Rush, (D-Ill.)
- May 21, 2013 — Additional cosponsor(s): 1
- Valadao, (R-Calif.)
- May 17, 2013 — Additional cosponsor(s): 3
- Latham, (R-Iowa) Long, (R-Mo.) Olson, (R-Texas)
- May 15, 2013 — Energy & Commerce Committee vote: Prescription Drug Tracking-Vote to ReportOrdered reported favorably to the full House (as amended) by voice vote.
- May 15, 2013 — Full committee consideration and markup held by the House Energy and Commerce Committee.
- May 15, 2013 — Committee Vote: Prescription Drug Tracking — Definition and Technical Changes Latta, R-Ohio —
- Amendment that would make several definition and technical changes to the bill.
- One change would alter the definition of a "dispenser" to include warehouses and distribution centers under common ownership of entities such as pharmacies. However, this would only be to the extent that the warehouses and distribution centers do not act as wholesale distributors.
- The term "transaction" would not include the distribution of a product by a dispenser or wholesale distributor to a repackager that is already under the dispenser’s control.
- The original version of the bill would prevent repackagers from accepting ownership of a prescription drug product unless the previous owner provides transaction history, starting on Jan. 1, 2015. Under the amendment, the requirements for ownership changes would begin by April 1, 2015 if a repackager received a prescription drug product from a wholesale distributor.
- Adopted by voice vote.
- May 15, 2013 — Committee Vote: Prescription Drug Tracking — Electronic and Interoperable System Pallone, D-N.J. —
- Amendment that would require the implementation of an electronic and interoperable tracking system within 10 years after the legislation is enacted. It also would not make the creation of such a system contingent upon whether the FDA finalizes regulations.
- Rejected 19-28.
- May 15, 2013 — Committee Vote: Prescription Drug Tracking — Returned Products Engel, D-N.Y. —
- Amendment that would allow wholesale distributors to accept returned prescription drug products without transaction histories from dispensers. However, wholesale distributors would need transaction histories if they wanted to enter the products back into the market.
- Rejected 20-29.
- May 15, 2013 — Committee Vote: Prescription Drug Tracking — Pedigree Requirements Castor, D-Fla. —
- Amendment that would allow the striking of prescription drug pedigree requirements effective starting in 2015.
- Rejected by voice vote.
- May 15, 2013 — Committee Vote: Prescription Drug Tracking — State Policies Capps, D-Calif. —
- Amendment that would require states to only change their policies if they are "less stringent" than the national regulations, rather than if they are more stringent or inconsistent with national policies.
- Rejected by voice vote.
- May 15, 2013 — Committee Vote: Prescription Drug Tracking — Vote to Report
- Establish a national unit-level tracking system for prescription drugs. Under the legislation, all entities of the prescription drug supply chain would be required to submit information about their products.
- The bill would outline a process for the Food and Drug Administration and stakeholders to collaborate on the creation of a electronic and interoperable tracking system. The FDA would propose regulations by 2027. If the regulations were finalized, they would take effect within two years.
- Manufacturers would be required to submit prescription drugs' transaction histories starting on Jan. 1, 2015. This requirement would be phased in for wholesale distributors and pharmacies
- As amended, the measure would alter the definitions of the terms "dispenser" and "transaction," as well as clarify how repackagers could accept ownership of a prescription drug product.
- Ordered reported favorably to the full House (as amended) by voice vote.
- May 15, 2013 — Related measure, S 957, introduced by Bennet, D-Colo.
- May 14, 2013 — Full committee consideration and markup held by the House Energy and Commerce Committee.
- May 9, 2013 — Latta, R-Ohio, Submits a constitutional authority statement on the legislation. Congressional Record p. H2569
- May 9, 2013 — Original cosponsor(s): 12
- Blackburn, M. (R-Tenn.) Guthrie, (R-Ky.) Rogers, Mike (R-Mich.) Burgess, (R-Texas) Johnson, B. (R-Ohio) Schneider, (D-Ill.) Cassidy, (R-La.) Matheson, (D-Utah) Shimkus, (R-Ill.) Dingell, (D-Mich.) McKinley, (R-W.Va.) Upton, (R-Mich.)
- May 9, 2013 — Read twice and referred to: House Energy and Commerce.Congressional Record p. H2567