The FDA has announced that it will prioritize applications for new generic drugs that could alleviate drug shortages or address public health needs. The agency’s revised procedure manual changes how abbreviated new drug applications (ANDAs) are prioritized for review.
Previously, the FDA reviewed applications based on when they were filed, even if the drug would not be available on the market for some time, because of patent restrictions. Under the new policy an original ANDA must meet certain criteria in order to have a priority review, such as whether the submission relates to a drug shortage or public health emergency.
Read more about drug shortages in dermatology in Dermatology World.
DW Insights and Inquiries: Twenty years of imiquimod taking its toll on lentigo maligna: Where are we?
Although Y2K never amounted to much, a solitary case report that year changed the dynamic in treating a vexing problem — melanoma in situ of the lentigo maligna (LM) subtype. Ahmed and Berth Jones reported treating an 88-year old man with a large LM of his scalp with imiquimod 5% cream. The authors initially treated a test area and then the whole lesion for 7 months. Imiquimod resulted in complete clinical and histological cure. The patient was followed up to 9 months without evidence of recurrence.
Since the inaugural report there have been at least 125 PubMed references discussing imiquimod for managing LM — what have we learned? Keep reading!
CMS updates MIPS Explore Measures Tool for 2020
CMS has updated its Explore Measures Tool to include measures for all four of the MIPS categories for the 2020 reporting year. The tool allows MIPS participants the opportunity to get familiar with the different measures they can submit and prepare for the year.
For more information and resources for 2019 MIPS reporting, visit the Academy’s MIPS reporting resource center, and check out a list of new and revised dermatology-specific quality measures, including several new melanoma measures for MIPS reporting. If you’re reporting using DataDerm™, the 2019 MIPS Reporting Module can still be purchased by calling the Academy’s Member Resource Center at 866-503-SKIN (7546).
Derm Coding Consult: AMA CPT releases new online digital E/M services codes for private payers
What are the hazardous effects of e-cigarettes on the skin?
Research published online in JAAD has found that in addition to having serious heart and lung consequences, e-cigarettes are also harmful to the skin and associated with some immediately visible health concerns, including serious explosion and burn injuries, contact dermatitis, and increased risk of oral cancer.
The paper authors stated that “Dermatologists should be more cognizant of electronic cigarette use when taking a social history of patients presenting with new oral lesions, contact dermatitis, or burn injuries.”
Read more about the cutaneous manifestations that can result from vaping in a recent issue of DW Insights and Inquiries.
President Trump declares public health emergency over coronavirus
The Trump Administration has declared a public health emergency over the coronavirus. However, HHS Secretary Alex Azar, the lead of President Trump’s coronavirus task force, said, “The risk of infection for Americans remains low. We are working to keep the risk low.”
U.S. citizens who have returned from China’s Hubei province in the last two weeks will undergo health screenings. Those still returning will be funneled through one of seven designated airports. Additionally, Sec. Azar also announced a temporary suspension of entry into the United States of foreign nationals who pose a risk for the transmission of the coronavirus.
Read more about the cultural factors at play in the re-emergence of infectious disease in Dermatology World.
Is nadolol a safe option for infantile hemangioma?
A recent paper in Pediatrics examined whether nadolol, a nonselective beta blocker, is a safe alternative to propranolol for infantile hemangioma. Propranolol, another nonselective beta blocker, is currently FDA-approved for infants with infantile hemangioma. While propranolol is metabolized by the liver and excreted renally, nadolol is excreted in the feces. In the paper, the authors discuss the death of an otherwise healthy infant while on nadolol therapy for infantile hemangioma but had not had a bowel movement for 10 days prior to her death, which the authors hypothesize contributed to nadolol toxicity.
The authors concluded that “Propranolol may be a safer therapy overall. Not only does it have a shorter half-life, but propranolol is hepatically metabolized and renally eliminated, allowing for less drug accumulation in healthy infants with variable stooling patterns.”
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