Amendments Offered for Bill on FDA Funding, Safety

Sen. Byron Dorgan (D-N.D.) has requested the inclusion of three amendments he proposed Tuesday in a manager's package of amendments for a bill (S 1082) that would reauthorize the Prescription Drug User Fee Act, CongressDaily reports.

According to CongressDaily, two of the amendments, which Dorgan proposed "after being handed a defeat" on prescription drug reimportation, "appear to be tongue-in-cheek rebukes to importation foes, including the pharmaceutical industry" (Edney, CongressDaily, 5/9).

The Senate on Monday by voice vote approved an amendment proposed by Dorgan and Sen. Olympia Snowe (R-Maine) that would allow reimportation. However, before the vote, the Senate voted 49-40 to approve a second-degree amendment proposed by Sen. Thad Cochran (R-Miss.) that would not allow reimportation until the HHS secretary certifies the practice would "pose no additional risk to the public's health and safety" and would significantly reduce costs for consumers.

The approval of the Cochran amendment effectively nullified the Dorgan amendment because HHS secretaries in the current and previous administrations have refused to certify the safety of reimportation (California Healthline, 5/8).

One of the three amendments Dorgan proposed on Tuesday would require HHS to certify the safety of medications sold in the U.S., "essentially applying the Cochran amendment to domestic prescription drugs," CongressDaily reports.

Dorgan spokesperson Barry Piatt said the amendment "would force the issue that they're asking the impossible" with the Cochran amendment.

A second Dorgan amendment would require medications to include labels that indicate the nation where they were manufactured.

Piatt said that the amendment is a response to reimportation opponents who question the safety of the practice, although pharmaceutical companies currently sell medications in the U.S. that were manufactured at facilities in other nations.

A third Dorgan amendment would require the placement of tracking devices on medications to prevent counterfeiting (CongressDaily, 5/9).

The Senate this week will continue to finalize the manager's package of amendments to the reauthorization bill and determine which amendments will receive votes (CongressDaily, 5/8).