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Executive Summary

FDA ENFORCEMENT BILL (HR 3642) REPORTED OUT OF HOUSE ENERGY & COMMERCE Committee on July 9 by a vote of 27-16 split along party lines. The bill voted out of the committee was a substitute amendment offered by Rep. Waxman (D-Calif.). With a few minor changes and amendments, the measure is very similar to a staff draft proposal floated during the spring aimed at consolidating Democratic support for the bill ("The Pink Sheet" April 6, T&G-6). The new version of HR 3642 that will go before the full House gives FDA less sweeping subpoena power than the bill that cleared the Energy & Commerce/Health subcommittee last autumn ("The Pink Sheet" Oct. 14, 1991, p. 3). The latest version of FDA enforcement legislation also reduces civil money penalties, gives the agency narrower record inspection authority and provides additional due process protections. The new bill's provision for administrative and judicial recall powers, like the earlier draft proposal, would bring FDA recall powers for all regulated products in line with the Safe Medical Devices Act of 1990. The bill also adds a new provision that specifically limits the delegation of the HHS Secretary's authority to issue a recall order "to the [FDA] commissioner or a single deputy commissioner." The section of the bill giving FDA temporary detention authority also has been revised and now distinguishes drugs and devices from foods and cosmetics. Under the new bill, FDA would have the same embargo authority for drugs as it now has for devices. For foods and cosmetics, the new version of the bill specifically limits the detention period to 20 days unless HHS authorizes an extension of up to 30 days. The bill provides two exceptions: "seasonal" foods and cosmetics, which could be detained for only seven days, and "perishable products," which could not be detained for more than two days unless HHS specifically authorizes an extension of the embargo up to seven days. An amendment offered by Rep. Kostmayer (D-Penn.) and added to the bill would require HHS to consider the shelf life of a drug or device and whether it is "in short supply" when ordering an embargo. The civil monetary penalties in the new version of the enforcement bill are the same as those in the discussion draft and in the revised Senate version of the bill (S 2135): $15,000 per violation for individuals and $50,000 per violation for companies with a maximum penalty of $1 mil. for violations of the FD&C Act. However, for "knowingly" committing fraud or bribery, the penalties are $250,000 per violation for individuals and $1 mil. for companies. The revised section on civil monetary penalties eliminates the free-standing subpoena provision and limits subpoena powers to matters under civil investigation. The bill's provision for civil penalties would be prospective from the time of enactment and would not allow the initiation of a criminal action if a civil penalty already has been assessed. The section of the new bill relating to FDA inspections is essentially unchanged from the discussion draft. The bill extends the same record inspection authority the agency now has for prescription drugs to medical devices and OTC drugs. Inspection authority also would be extended to foods and cosmetics but only for ingredients, quality control tests pertaining to a safety concern identified by the agency, tests conducted under the Nutrition Labeling and Education Act and consumer complaints related to safety and food processing records. In addition, inspectors would be limited to taking photographs of apparent violations of the law. An amendment offered by Rep. Richardson (D-N.M.) to clarify that HR 3642 does not change the law governing FDA's regulation of vitamins, minerals and herbs was passed on a voice vote. Committee Chairman Dingell (D-Mich.) said the FDA enforcement legislation will "establish a level playing field" for "honest and intelligent" businesspeople and provides for the "protection of honest men among consumers and among industries." Republican members speaking against the bill claimed it lacked safeguards to protect trade secrets, is not warranted by the risks to public health and safety, might be burdensome for small businesses and is unnecessary given the revitalization under way at FDA under Commissioner Kessler. HHS Secretary Sullivan wrote Dingell on June 22 to voice the Administration's opposition to the amended HR 3642, promising a presidential veto if the bill is passed.

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