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LOBBYING REPORT |
Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page
2. Address
Address1 | 4510 Executive Drive |
Address2 | |
City | San Diego |
State | CA |
Zip Code | 92101 |
Country | USA |
3. Principal place of business (if different than line 2)
City | San Diego |
State | CA |
Zip Code | 92101 |
Country | USA |
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5. Senate ID# 400552652-12
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6. House ID# 414650000
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TYPE OF REPORT | 8. Year | 2011 |
Q1 (1/1 - 3/31) | Q2 (4/1 - 6/30) | Q3 (7/1 - 9/30) | Q4 (10/1 - 12/31) |
9. Check if this filing amends a previously filed version of this report
10. Check if this is a Termination Report | Termination Date | |
11. No Lobbying Issue Activity |
INCOME OR EXPENSES - YOU MUST complete either Line 12 or Line 13 | |||||||||
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12. Lobbying | 13. Organizations | ||||||||
INCOME relating to lobbying activities for this reporting period was: | EXPENSE relating to lobbying activities for this reporting period were: | ||||||||
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Provide a good faith estimate, rounded to the nearest $10,000, of all lobbying related income for the client (including all payments to the registrant by any other entity for lobbying activities on behalf of the client). | 14. REPORTING Check box to indicate expense accounting method. See instructions for description of options. | ||||||||
Method A.
Reporting amounts using LDA definitions only
Method B. Reporting amounts under section 6033(b)(8) of the Internal Revenue Code Method C. Reporting amounts under section 162(e) of the Internal Revenue Code |
Signature | Digitally Signed By: Madeleine D. Baudoin, Associate Director of Public Policy |
Date | 10/31/2011 |
LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.
15. General issue area code HCR
16. Specific lobbying issues
Discussed concerns over the impact medical device and drug FDA regulation has on innovation, jobs, patients and the economy. Addressed changes to 510K process and concerns over an increasingly unpredictable regulatory system. Adressed concerns over lack of effective communication between FDA and industry, as well as administrative issues such as concerns over the FDA's access to training and education on the newest technologies.
Addressed concerns over proposed new limitations on the scope of RUO and IUO products. Discussed concern that the proposed restrictions would negitively impact the practice of developing and validating clinical tests using RUO and IUO components, and would significantly change the way manufacturers can promote and sell their products, and in so doing irreparably harm innovation in this area.
Addressed BIOCOM's support for a 12 year data exclusivity period for biologic products and our strong opposition to any proposed reduction to the 12 year data exclusivity period.
Addressed opposition to the IOM's recommendation to dismantle the FDA 510K process.
Support HR 2182, The Generating Antibiotic Incentives Now ("GAIN") Act.
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Food & Drug Administration (FDA)
18. Name of each individual who acted as a lobbyist in this issue area
First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Joe |
Panetta |
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Madeleine |
Baudoin |
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Jimmy |
Jackson |
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19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.
15. General issue area code MED
16. Specific lobbying issues
Support for HR 1862, the Regenerative Medicine Promotion Act.
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES
18. Name of each individual who acted as a lobbyist in this issue area
First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Joe |
Panetta |
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Madeleine |
Baudoin |
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Jimmy |
Jackson |
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19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.
15. General issue area code TAX
16. Specific lobbying issues
Support Medical Device Excise Tax Repeal Efforts
Support HR 1988, the Theraputic Tax Credit Extension Act of 2011
Support HR 2632, the Life Science Jobs and Investment Act
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE
18. Name of each individual who acted as a lobbyist in this issue area
First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Joe |
Panetta |
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Madeleine |
Baudoin |
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Jimmy |
Jackson |
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19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.
15. General issue area code MMM
16. Specific lobbying issues
Addressed opposition over the Independent Payment Advisory Board ("IPAB"). Expressed concern over the IPAB which is an unelected body that could institute broad changes to Medicare with no Congressional input or oversight.
Opposed proposed cuts to Medicare Part D, which provides seniors with a drug benefit, and Part B, which provides oncology products for administration in physicians offices.
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES
18. Name of each individual who acted as a lobbyist in this issue area
First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Joe |
Panetta |
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Madeleine |
Baudoin |
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Jimmy |
Jackson |
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19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.
15. General issue area code CPT
16. Specific lobbying issues
Address issues related to HR/1249 and S 23, the patent reform legislation, including support for fee retention, and putting an end to qui tam complaints for alleged false markings.
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE
18. Name of each individual who acted as a lobbyist in this issue area
First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Joe |
Panetta |
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Madeleine |
Baudoin |
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Jimmy |
Jackson |
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19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
Information Update Page - Complete ONLY where registration information has changed.
20. Client new address
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21. Client new principal place of business (if different than line 20)
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22. New General description of client’s business or activities
LOBBYIST UPDATE
23. Name of each previously reported individual who is no longer expected to act as a lobbyist for the client
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ISSUE UPDATE
24. General lobbying issue that no longer pertains
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AFFILIATED ORGANIZATIONS
25. Add the following affiliated organization(s)
Internet Address:
Name | Address |
Principal Place of Business (city and state or country) |
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26. Name of each previously reported organization that is no longer affiliated with the registrant or client
1 | 3 | 5 |
2 | 4 | 6 |
FOREIGN ENTITIES
27. Add the following foreign entities:
Name | Address |
Principal place of business (city and state or country) |
Amount of contribution for lobbying activities | Ownership percentage in client | ||||||||||
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28. Name of each previously reported foreign entity that no longer owns, or controls, or is affiliated with the registrant, client or affiliated organization
1 | 5 | 9 |
2 | 6 | 10 |
3 | 7 | 11 |
4 | 8 | 12 |