News in Brief: Week of Nov. 11-15

November 13, 2013 02:58 pm News Staff

This roundup includes the following news briefs:

FDA Proposing Changes to Generic Drug Safety Information Updates

The FDA is proposing a rule(www.federalregister.gov) that will speed the dissemination of new safety information about generic drugs to family physicians and other health professionals, as well as patients. The rule would allow generic drug manufacturers to use the same process as brand-name drug manufacturers to update safety information in product labeling.

According to an FDA release(www.fda.gov), generic drug manufacturers would be able to independently update prescribing information with newly acquired safety information before the FDA reviews the change, just like brand-name drug manufacturers. Generic manufacturers also would be required to inform the brand-name manufacturer about the change.

The FDA then would evaluate whether the proposed change is justified and make an approval decision on changes to both the generic and corresponding brand-name drug label, allowing both products to have the same FDA-approved prescribing information.

"This proposal will help ensure that health care professionals and consumers have access to the latest safety information for the medications they use," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, in the release. "More than 80 percent of prescriptions filled in the (United States) are for generics, so we want to make sure that generic drug companies actively participate with the FDA to ensure that product safety information is accurate and up-to-date."

The FDA is seeking public comment(www.federalregister.gov) on the proposed rule until 5 PM ET on Jan. 13, 2014.

Ponatinib Recalled Because of Clotting Risk

According to an FDA release(www.fda.gov), Ariad Pharmaceuticals has agreed to suspend marketing and sales of its leukemia chemotherapy drug ponatinib (Iclusig) because of the risk of life-threatening blood clots and severe narrowing of blood vessels associated with the drug.

The FDA said it will continue to evaluate the drug to further understand its risks and to identify potential patient populations in which the benefits of the drug may outweigh the risks.

The FDA also is providing instructions to family physicians and other health care professionals whose patients have been taking ponatinib and are benefiting from the drug on how to continue these patients on the treatment.

AAFP members can report adverse events linked to drugs and biologic agents via RxEvent, an adverse drug event reporting service that has partnered with the Academy. All physicians, health care professionals and patients can report such events through MedWatch(www.accessdata.fda.gov), the FDA's safety information and adverse event reporting program.

Request Review of 2012 PQRS Participation Results

Family physicians and other eligible professionals who submitted data for the 2012 Physician Quality Reporting System (PQRS) can request an informal review of their reporting performance(www.cms.gov).

The informal review will include all 2012 reporting methods: claims, a quality registry, a qualified electronic health record, or group practice reporting option for groups of 100 or more physicians or other eligible providers.

Physicians or their designated support staff must request a PQRS review via the Quality Reporting Communication Support Page(www.qualitynet.org) from Nov. 1 through Feb. 28. From the options offered, choose "Create Informal Review Request." (Depending on the browser you use, you may need to temporarily allow pop-ups to enter the portal.) Physicians will receive an email within 90 days of their submission with the review decision outcome. All decisions are final and cannot be appealed.

Need help? Contact the QualityNet Help desk by phone at (866) 288-8912 or send an email to Qnetsupport@sdps.org.

HHS Awards $150 Million to Fund New Community Health Centers

HHS recently announced awards totaling more than $150 million that will help support primary care services in 236 communities around the country. The grants will fund new community health center sites and provide health care access to more than 1.25 million new patients.

According to a Nov. 7 press release from HHS(www.hhs.gov), staff members in the community health centers also will help individuals sign up for health insurance in the health insurance marketplaces mandated by the Patient Protection and Affordable Care Act.

A list of organizations that received grants is available online(www.hrsa.gov). Click on individual states to see the names of specific awardees and grant amounts.

AAFP Foundation Guides Aid Dollars to Philippines Typhoon Relief Efforts

The AAFP Foundation(www.aafpfoundation.org) offers family physicians a quick and easy way to donate to the ongoing relief efforts in the aftermath of Super Typhoon Haiyan, which recently devastated the Philippines.

News reports tell of 200 mile-per-hour winds and a significant storm surge that has killed thousands of people -- with the death toll still rising -- and demolished entire villages.

The Foundation ensures timely and effective aid by working with its partner organizations -- Heart to Heart International and International Medical Corps -- which already are mobilizing efforts to bring food, water and medicine to the hardest hit areas. Donations can be targeted specifically to the current Philippines disaster.


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