Synopsis Of Draft "Federal Drug Safety Act of 2005"

By Paul G. King, Ph.D., Pharmaceutical, Regulatory & Analytical Scientist (

Comments and recommendations: Please email Dr. Paul G. King

The Federal Drug Safety Act of 2005 is based on the reality that only Congress can solve the problem by legislating to correct the statutes in a manner that addresses the problems that the current statutes do not, because the FDA has clearly failed to solve these problems.

This draft legislation primarily seeks to give the FDA better and more appropriate rules that address the most important weaknesses in the current Federal Food, Drug, and Cosmetic Act as amended with respect to drugs and drug products as follows:

  1. First, the draft legislation halves and focuses the FDA’s mission so that the Agency’s mission is only to protect the health of the American public. (SEC. 3. FOOD AND DRUG ADMINISTRATION MISSION AND REPORT)
  2. Then, it modifies the definition of adulterated drugs to bring that definition up to: (SEC. 4. ADULTERATED DRUGS)
    1. Today’s recognized minimum industry standard for non-uniformity of other high-risk or high-quality products produced in America since 1990, and
    2. An appropriate commercial standard for the minimum content of the active drug in the drug product units so that each patient is assured of getting close to the level of drug in each "pill" that the labeling states was provided.
  3. Next, it modifies the definition of misbranded drugs to require the packager of the finished dosage units to disclose the country of origin of the dosage units packaged in each finished packaged product container. (SEC. 5. MISBRANDED DRUGS)

[Note: This "truth in labeling" provision was added so that the consumer can be certain of the country of origin of the drug product units in each drug product package. This is needed because the industry is increasingly making the drug product units in foreign countries, and then importing and packaging them in the US with labels that, by only identifying the name and location of the packager, mislead the consumer into believing that the drug was made in the US. This provision makes that knowingly deceptive practice illegal. This practice also gives lie to the Drug Lobby’s feigned concern about the problems with drug importation from countries outside of the US – the consumer should not be able to do, but the industry should – a hypocritical double standard, at best.]

  1. Then, it fixes the broken drug establishment inspection mandate for biannual (not less than every two years) inspection of each accepted drug facility. This inspection mandate is so broken that the current average interval between inspections is more than 4 years and, as the recent flu vaccine incident clearly proves, does not effectively ensure that the inspected facilities are clean, much less operated in a proper manner. This section provides a funding source and incentives for the Agency and the industry for the requisite inspections, and increasing the mandated inspection frequency to annual when problems are found. (SEC. 6. ESTABLISHMENT INSPECTIONS)

[Note: By contrast, food purveyors are given unannounced inspections by the federal government, state inspectors, and county and/or city inspectors at a much higher frequency and restaurants are given unannounced inspections at least annually. In most cases, these pay state and/or local licensing fees to support the inspections. Since this system works for ensuring the safety of restaurants while the federal system for drug facilities is broken, this legislation simply adapts the successful state/local system to the federal system. Further, the proposed draft halts distribution from facilities with significant problems (like Chiron’s English facility) until: a) the problems are corrected and b) the facility is found to be acceptable in a subsequent inspection. Until the Agency meets its statutory mandates, the Agency is banned from approving new facilities unless they are for a condition for which there is no current drug. Further, since the FDA has no direct jurisdiction over foreign facilities, this section embargoes all of that firm’s products from landing in the US (with a well-defined exception for drugs with no alternative) until the problems found are fixed and the violative facility passes an inspection.

  1.  Next, the draft legislation addresses the long-standing problems with manufacturer’s releasing substandard drug batches by:  (SEC. 7. QUALITY VERIFICATION)
    1. Requiring then to properly (to ISO standards) report the analytical values for the critical drug characteristics,
    2. Providing for the Agency to randomly test batches to ensure that they are safe and meet their quality standards,
    3. Using the statistical capability values generated to identify problem products and take appropriate actions to stop the marketing of such, and
    4. Establishing a read-only database for all such data submitted to the agency or found by the Agency so that the public can independently assess the quality and conformity to requirements of each firms marketed products.
  2. Further, the draft changes the drug approval process so that it is better aligned with the licensing process used for biological products in a manner that: a) explicitly defines the acceptable safety risk level and confidence level for drug approval, b) facilitates the withdrawal of drugs with significant post-approval safety problems (like Rezulin, Vioxx, and Phen-Fen), c) sets clear minimum postrelease relative safety standards that are appropriate for both "me too" drugs (like Baycol) and truly new drugs, d) explicitly requires appropriate long-term Phase IV studies for each newly approved drug and the reporting of all findings of such studies in an open-to-the-public database, and e) requires that all existing policy and guidance documents be reviewed and those that conflict with the Federal Food, Drug, and Cosmetic Act as amended or any binding regulation be withdrawn. (SEC. 8. REFUSING TO ACCEPT A NEW DRUG APPLICATION, WITHDRAWAL OF ACCEPTANCE, AND OTHER CHANGES)
  3. The next section proposed simply defines and limits all direct-to-the-consumer communication by the industry to communication that is ONLY educational in nature. (SEC. 9. ALL DIRECT-TO-THE-CONSUMER SPEECH DEFINED AS COMMERCIAL SPEECH AND REGULATED AS SUCH)
  4. Then, the draft essentially broadens the current "generic drug" debarment provisions to address the entire drug industry by striking the limitation to abbreviated drug applications and updates the maximum penalties to account for inflation and provide for automatic inflation/deflation-indexing of the maximum penalties. (SEC. 10. REVISING THE FOOD AND DRUG ADMINISTRATION TO BROADEN THE DEBARMENT PROVISIONS APPROPRIATELY)
  5. Next, the draft simply requires the restructuring of the FDA so that ensuring drug safety and the enforcement of the laws regulating industry conduct are again at least as important as the drug development, review and approval activities as they: a) should be, but b) are not now. (SEC. 11. RESTRUCTURING THE FOOD AND DRUG ADMINISTRATION TO EMPHASIZE ENFORCEMENT AND SAFETY)
  6. Finally, to address a component of the effective enforcement of law that the FDA lacks but other effective regulatory agencies, like OSHA, have, the draft includes implementing provisions for administrative penalties related to industry compliance lapses. (SEC. 12. ADMINISTRATIVE PENALTIES FOR COMPLIANCE LAPSES)

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