Trending News Today: FDA Accelerated Pathways Speed Approvals Up to 1 Year

A new JAMA study found that ongoing accelerated medication development programs significantly shorten time to FDA approval, with some drugs coming to market up to a year sooner than they would without these programs, the Los Angeles Times reported. Quicker approval times can lead to novel drugs getting to patients sooner, while also increasing manufacturer profits, according to the report. The authors found that 60% of treatments approved between 2012 and 2016 were accelerated under 1 of the 4 programs. These drugs took between 5.1 years and 10.1 years to advance from clinical trials to approval, while non-accelerated drugs took between 6.5 years and 10 years, according to the article.

A 2004 clinical trial demonstrated that reducing allergens in the home also lessened asthma symptoms; however, this approach was not largely adopted by families due to financial concerns, lack of control over their home environment, and denial of insurance coverage, Kaiser Health News reported. Since intensive professional cleaning would require a different type of funding than Medicaid waivers, physicians and researchers felt this approach would not be widely implemented despite the potential benefits, according to the article. Additionally, insurers were concerned that paying for the cleaning would not lessen their overall costs. A more recent study suggests that families who receive training can significantly reduce allergens on their own, which provides them with another option, according to Kaiser.

The Republican Study Committee is pushing for a repeal of the Affordable Care Act individual mandate in the final version of the tax reform bill, according to The Hill. While the Senate approved a version of the bill that included the repeal, the House version of the legislation did not. The committee said that repealing the provision would allow Americans to make their own health care choices, according to the article. The House and Senate must now agree on and pass a final tax reform bill, which may be difficult due to differences in opinions among competing constituencies.

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This application-based activity will focus on the pharmacist's role in the management of patients with poorly controlled asthma through counseling and patient education. It will also present the current treatment guidelines and the advantages and disadvantages of each medication.
Asthma is a common, chronic problem affecting up to 18% of the population in different countries. It is defined as a heterogeneous disease usually characterized by chronic airway inflammation. Asthma symptoms are variable and can intensify and vary over time due to multiple environmental and/or health conditions. It is important that all members of the healthcare team understand the nature and variability of asthma. As an integral member of the healthcare team, pharmacists also need to recognize the conditions that can mimic symptoms of asthma or be found in conjunction with asthma.
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