Inside Washington Publishers http://healthpolicynewsstand.com/FDA-Week/FDA-Week-10/01/2010/feed/atom/menu-id-315.html 2010-10-13T04:11:27Z Joomla! 1.5 - Open Source Content Management 2010-10-01T00:02:06Z 2010-10-01T00:02:06Z http://healthpolicynewsstand.com/FDA-Week/FDA-Week-10/01/2010/industry-concerned-with-drug-safety-bills-fees-data-confidentiality/menu-id-721.html Administrator [email protected]

The pharmaceutical industry's three top trade groups have informed lawmakers they have concerns with Democrats' draft drug safety legislation, particularly that the measure permits collected fees to be used for non-foreign inspection-related issues, leaves many elements of the fees unanswered and does not fully protect confidential information. The groups, in comments prepared for a canceled Capitol Hill hearing, urged lawmakers to consider exempting certain investigational products from the legislation's requirements and said a third-party audit program and improved international coordination could help support the bill's foreign inspection program.

The pharmaceutical industry's three top trade groups have informed lawmakers they have concerns with Democrats' draft drug safety legislation, particularly that the measure permits collected fees to be used for non-foreign inspection-related issues, leaves many elements of the fees unanswered and does not fully protect confidential information. The groups, in comments prepared for a canceled Capitol Hill hearing, urged lawmakers to consider exempting certain investigational products from the legislation's requirements and said a third-party audit program and improved international coordination could help support the bill's foreign inspection program. 2010-10-01T00:02:06Z 2010-10-01T00:02:06Z http://healthpolicynewsstand.com/FDA-Week/FDA-Week-10/01/2010/harkin-plans-to-investigate-fdas-biodefense-countermeasures-role/menu-id-721.html Administrator [email protected]

Sen. Tom Harkin (D-IA) questioned this week whether FDA has enough resources to properly tackle biodefense countermeasures development and said he plans to examine whether to strip the agency of some of its duties, amid White House efforts to boost some of FDA's biodefense funding and an HHS proposal to enhance the agency's role in the area. In order to enhance the agency's medical countermeasures program, a biosecurity advocate suggested that FDA create a specific center dedicated to addressing the issue, with Harkin expressing some interest in the idea.

Sen. Tom Harkin (D-IA) questioned this week whether FDA has enough resources to properly tackle biodefense countermeasures development and said he plans to examine whether to strip the agency of some of its duties, amid White House efforts to boost some of FDA's biodefense funding and an HHS proposal to enhance the agency's role in the area. In order to enhance the agency's medical countermeasures program, a biosecurity advocate suggested that FDA create a specific center dedicated to addressing the issue, with Harkin expressing some interest in the idea. 2010-10-01T00:02:06Z 2010-10-01T00:02:06Z http://healthpolicynewsstand.com/FDA-Week/FDA-Week-10/01/2010/harkin-criticizes-hhs-plan-to-redirect-flu-funds-to-dod/menu-id-721.html Administrator [email protected]

A key Senate lawmaker chastised HHS this week for its plan to redirect Project Bioshield procurement funds to the Department of Defense and raised concerns that the U.S. is falling behind in developing cell-based vaccine technologies, despite stating that HHS' proposal to strenghten its medical countermeasures enterprise is generally a good plan.

A key Senate lawmaker chastised HHS this week for its plan to redirect Project Bioshield procurement funds to the Department of Defense and raised concerns that the U.S. is falling behind in developing cell-based vaccine technologies, despite stating that HHS' proposal to strenghten its medical countermeasures enterprise is generally a good plan. 2010-10-01T00:02:06Z 2010-10-01T00:02:06Z http://healthpolicynewsstand.com/FDA-Week/FDA-Week-10/01/2010/sharfstein-jaampj-recall-response-exemplifies-fda-need-for-new-authority/menu-id-721.html Administrator [email protected]

Mandatory recall authority would have allowed for a quicker response and better oversight of Johnson & Johnson's recalls of children's medicines and Motrin, a top agency official told lawmakers Thursday (Sept. 30). Mandatory drug recall authority is a core tenet of recently drafted drug safety legislation that is being prioritized for passage by key lawmakers.

Mandatory recall authority would have allowed for a quicker response and better oversight of Johnson & Johnson's recalls of children's medicines and Motrin, a top agency official told lawmakers Thursday (Sept. 30). Mandatory drug recall authority is a core tenet of recently drafted drug safety legislation that is being prioritized for passage by key lawmakers. 2010-10-01T00:02:06Z 2010-10-01T00:02:06Z http://healthpolicynewsstand.com/FDA-Week/FDA-Week-10/01/2010/johns-hopkins-contracted-for-applied-cer-initiative/menu-id-721.html Administrator [email protected]

FDA's highly watched comparative effectiveness research program is now on the verge of being fully operational, with the agency contracting Johns Hopkins University to lead a program that will help answer questions on patient sub-populations and classes of products through the Partnership in Applied Comparative Effectiveness Science initiative, sources said.

FDA's highly watched comparative effectiveness research program is now on the verge of being fully operational, with the agency contracting Johns Hopkins University to lead a program that will help answer questions on patient sub-populations and classes of products through the Partnership in Applied Comparative Effectiveness Science initiative, sources said. 2010-10-01T00:02:06Z 2010-10-01T00:02:06Z http://healthpolicynewsstand.com/FDA-Week/FDA-Week-10/01/2010/fda-pressed-to-halt-ge-salmon-approval-process-weigh-new-framework/menu-id-721.html Administrator [email protected]

House and Senate lawmakers are calling on FDA to halt its consideration of whether to approve genetically engineered salmon and weigh a new regulatory framework to tackle the issue. They raise concerns with the animal drug approval process the agency used, along with safety and environmental issues. Senate lawmakers sent a letter to FDA commissioner Margaret Hamburg on Tuesday (Sept. 28), while Rep. Frank Pallone (D-NJ) sent a letter to the agency last week. A letter with a similar objective was also endorsed by at least 20 House lawmakers.

House and Senate lawmakers are calling on FDA to halt its consideration of whether to approve genetically engineered salmon and weigh a new regulatory framework to tackle the issue. They raise concerns with the animal drug approval process the agency used, along with safety and environmental issues. Senate lawmakers sent a letter to FDA commissioner Margaret Hamburg on Tuesday (Sept. 28), while Rep. Frank Pallone (D-NJ) sent a letter to the agency last week. A letter with a similar objective was also endorsed by at least 20 House lawmakers. 2010-10-01T00:02:06Z 2010-10-01T00:02:06Z http://healthpolicynewsstand.com/FDA-Week/FDA-Week-10/01/2010/more-enforcement-likely-as-fda-cpsc-collaborate-on-infant-devices/menu-id-721.html Administrator [email protected]

Collaboration between FDA and the Consumer Product Safety Commission on infant sleeping devices resulted in a crackdown on the products' manufacturers, now requiring them to submit 510(k) applications for marketing clearance, with a top FDA official signaling that the inter-agency efforts could result in more enforcement actions.

Collaboration between FDA and the Consumer Product Safety Commission on infant sleeping devices resulted in a crackdown on the products' manufacturers, now requiring them to submit 510(k) applications for marketing clearance, with a top FDA official signaling that the inter-agency efforts could result in more enforcement actions. 2010-10-01T00:02:06Z 2010-10-01T00:02:06Z http://healthpolicynewsstand.com/FDA-Week/FDA-Week-10/01/2010/bio-consumers-pharmacies-push-for-fda-drug-insert-review/menu-id-721.html Administrator [email protected]

A broad swath of stakeholders -- including members of the drug industry, consumers and drug stores -- are resisting FDA's position that the agency cannot pre-review all drug information inserts under a new plan to develop a single document that would be distributed with medications, they told agency officials this week. Instead of lacking an FDA review of the proposed single document Patient Medication Information (PMI) inserts, stakeholders suggested examining new user fees or a tiered approach that would gradually review the consumer-oriented information based on risk and usage.

A broad swath of stakeholders -- including members of the drug industry, consumers and drug stores -- are resisting FDA's position that the agency cannot pre-review all drug information inserts under a new plan to develop a single document that would be distributed with medications, they told agency officials this week. Instead of lacking an FDA review of the proposed single document Patient Medication Information (PMI) inserts, stakeholders suggested examining new user fees or a tiered approach that would gradually review the consumer-oriented information based on risk and usage. 2010-10-01T00:02:06Z 2010-10-01T00:02:06Z http://healthpolicynewsstand.com/FDA-Week/FDA-Week-10/01/2010/delauro-proposes-mandated-ge-salmon-cloned-animal-food-labeling/menu-id-721.html Administrator [email protected]

A key House lawmaker introduced legislation Wednesday (Sept. 29) that would mandate labeling on genetically engineered salmon and cloned animal products, with the bill emerging as the agency weighs approval of transgenic salmon and after it held a public meeting on the labeling issue last week. Consumer advocates say they generally support the legislation, but remain more concerned that FDA will move forward to approve the transgenic salmon.

A key House lawmaker introduced legislation Wednesday (Sept. 29) that would mandate labeling on genetically engineered salmon and cloned animal products, with the bill emerging as the agency weighs approval of transgenic salmon and after it held a public meeting on the labeling issue last week. Consumer advocates say they generally support the legislation, but remain more concerned that FDA will move forward to approve the transgenic salmon. 2010-10-01T00:02:06Z 2010-10-01T00:02:06Z http://healthpolicynewsstand.com/FDA-Week/FDA-Week-10/01/2010/minimal-cer-data-pushed-for-one-doc-patient-drug-info-insert/menu-id-721.html Administrator [email protected]

As FDA evaluates transitioning the various types of patient drug information inserts into a single type of document, the agency could consider including some comparative effectiveness research information for consumers as identified in a template developed by two prominent scientists, sources said. A consumer advocate said minimal comparative information should be included to keep the document simple, while an industry source said the proposed development of Patient Medication Information (PMI) documents should not include that type of data.

As FDA evaluates transitioning the various types of patient drug information inserts into a single type of document, the agency could consider including some comparative effectiveness research information for consumers as identified in a template developed by two prominent scientists, sources said. A consumer advocate said minimal comparative information should be included to keep the document simple, while an industry source said the proposed development of Patient Medication Information (PMI) documents should not include that type of data.