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Analysis of H.R. 2427 (Rep. Gutknecht, "Pharmaceutical Market Access Act of 2003")
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Current Law |
H.R. 2427 |
| Condition of Effectiveness of Importation Section |
This section shall become effective only if the Secretary demonstrates to the Congress that the implementation of this section will pose no additional risk to the public's health and safety and result in a significant reduction in the cost of covered products to the American consumer. |
[LANGUAGE DELETED.] |
| When Regulations Must Be Promulgated |
Does not address timing. |
Requires Secretary to promulgate regulations within 6 months of enactment. |
| Persons Who May Import Covered Products |
Pharmacists and wholesalers. |
Pharmacists, wholesalers and qualifying individuals. A "qualifying individual" is an individual who is not a pharmacist or a wholesaler. |
| Safety Provisions |
Regulations shall require that safeguards be in place to ensure that each imported covered product complies with 21 USC 355 (safe and effective for intended use), 351 (not adulterated) and 352 (not misbranded), and other applicable requirements. |
Regulations shall require that each imported covered product complies with 21 USC 351 (not adulterated), 352 (not misbranded) and 355 (approved as safe and effective for its intended use by FDA), and other applicable requirements. |
| Discretionary Provisions in Regulations |
Allows Secretary to include any additional provisions in regulations as appropriate to protect public health or to facilitate importation of covered products. |
[LANGUAGE DELETED.] |
| Importation Records to be Provided to the Secretary |
Regulations shall require that records of importation be provided to the Secretary. |
Requirement shall apply only to pharmacists and wholesalers, not to "qualifying individuals." |
| Contents of Records |
Documentation from the foreign seller specifying the product's original source and amount of each lot of the product originally received. |
[LANGUAGE DELETED.] |
| Any other information that the Secretary determines to be necessary to ensure protection of public health. |
[LANGUAGE DELETED.] |
| Name, address, telephone, and professional license number of the importer. |
Professional license number of importer not required. |
| Testing |
Regulations shall require that testing be conducted by the importer of the covered product or the manufacturer of the product. |
Regulations shall require that testing be conducted by the importer of the covered product, unless the covered product is a prescription drug subject to [new] 21 USC 505B relating to counterfeit-resistant technologies (see below). Testing requirements shall only apply to importers who are wholesalers. |
| If testing is conducted by the importer, information authenticating the product and confirming that the labeling is in compliance shall be supplied by the manufacturer to the pharmacist or wholesaler; such information to remain confidential and used only for testing purposes. |
[LANGUAGE DELETED.] |
| Testing-related regulations may include additional provisions determined by the Secretary to protect trade secrets and confidential commercial information. |
[LANGUAGE DELETED.] |
| Country Limitations |
Covered products may only be imported only from countries listed in 21 USC 382(b)(1)(A) * or countries designated by the Secretary. |
Covered products may only be imported only from countries listed in 21 USC 382(b)(1)(A) * . |
| Suspension of Importations |
Secretary shall suspend importations of specific covered products or by specific importers upon discovery of importation pattern that is counterfeit or in violation of this section, until investigation is completed and the Secretary determines that public is adequately protected from counterfeit and violative products. |
Secretary shall suspend importations of specific covered products or by specific importers upon discovery of importation pattern that is in violation of this section, until investigation is completed. |
| Studies |
Study to be conducted comparing, inter alia, incidence of imported versus intra-U.S. shipments determined to be counterfeit, adulterated or misbranded. |
Study to be conducted comparing, inter alia, incidence of imported versus intra-U.S. shipments determined to be adulterated or misbranded. |
| Study requires Secretary to consult with USTR and USPTO to evaluate effect of importations on trade and patent rights. |
[LANGUAGE DELETED.] |
| Report |
Secretary to submit report to Congress describing study findings within 2 years after effective date of final regulations. |
Report to be submitted within 18 months of enactment. |
| Definition of "Covered Product" |
"Covered product" means a prescription drug, except it does not include a Schedule I, II or III controlled substance or a biological product as defined in 42 USC 262. |
[NO CHANGE.] |
| Sunset |
This section shall cease to have any legal effect upon the expiration of the 5-year period beginning on the effective date of final regulations. |
[LANGUAGE DELETED.] |
| Use of Counterfeit-Resistant Technologies to Prevent Counterfeiting |
[NO COMPARABLE PROVISION.] |
NEW:
A drug subject to 21 USC 353(b) [includes biological products] will be deemed to be misbranded unless its packaging complies with the new provisions regarding counterfeit-resistant technologies. |
| [NO COMPARABLE PROVISION.] |
NEW (21 USC 505B):
Secretary shall require the packaging of any drug subject to 21 USC 353(b) [includes biological products] to incorporate overt optically variable counterfeit-resistant technologies with equivalent function of security. Such technologies shall (1) be visible to the naked eye, providing for visual identification of product authenticity; (2) be similar to that used by Bureau of Engraving & Printing for U.S. currency; (3) be manufactured and distributed in a highly secure, tightly controlled environment; and (4) incorporate additional layers of non-visible covert security measures including forensic capability.Manufacturers shall incorporate these technologies into multiple elements of the physical packaging of the drugs, including blister packs, shrink wrap, labels, seals, bottles and boxes. Shipments of such products shall include a label on the shipping container that incorporates these technologies. Chain of custody procedures shall apply to such shipping labels. |
* Australia, Canada, Israel, Japan, New Zealand, Switzerland, and South Africa; member states of the European Union (Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden, and the United Kingdom); and countries in the European Free Trade Association (Iceland, Norway, and Liechtenstein). 21 USC 382(b)(1)(A). Note that ten additional countries are expected to be admitted to the European Union in 2004 (Cyprus, Malta, Hungary, Poland, the Slovak Republic, Latvia, Estonia, Lithuania, the Czech Republic and Slovenia).
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