Since taking office in 2017, FDA Commissioner, Scott Gottlieb, has been working on developing policies to reduce barriers to generic development and to accelerate the review of new generic drug applications. Gottlieb recognizes the important role generic drugs can play in lowering drug prices in the US, and he is committed to promoting increased market [...]
In the US, prescription drug prices are continuing to increase. In response to this, the FDA has come up with new initiatives to improve generic drug development and access. Generic drugs are cheaper alternatives to brand-named products, which increase competition on the market place. Although the FDA does not play a direct role in setting [...]
Medicine shortages and rising drug prices continue to plague the US healthcare system, despite efforts being made by government on the national and local level to combat the issue. As it stands, hospitals around the country are finding that they cannot access the products they need and are being forced to bear the brunt of [...]
Last month, the FDA released a draft guidance document suggesting investigators should stop using double blind, randomized clinical trials with placebo products, when developing treatments for certain malignant hematologic and oncologic diseases. In the three-page document, the agency explains the rationale behind this suggestion and proposes some alternative trial designs. Interested parties now have 60 [...]
Earlier this week, the FDA approved potassium chloride oral solution which is the first generic drug to receive a Competitive Generic Therapy (CGT) designation. This new approval pathway has been created as part of the FDA’s broader Drug Competition Action Plan. The agency recognizes the important role generic drugs can play in increasing competition and [...]
The US has had a hard time accepting biosimilar drugs, the copycat versions of biologics which are similar to the innovator product, but not exact replicas. To date, the FDA has approved only 11 biosimilar products, while the EMA has approved 25. Furthermore, of the 11 products that have been approved, 8 have been kept [...]
As part of the Trump administration’s efforts to address rising drug prices in the US, the FDA has recently published a list of brand name companies which have been using delaying tactics to actively block generic drug competition. FDA commissioner, Scott Gottlieb, has claimed that the purpose of this new initiative is not to shame [...]
Last month, FDA commissioner, Scott Gottlieb, touched on the agency’s shortcomings which have partly contributed to rising drug prices in the US. Speaking at a pharmaceutical event for pharmacy benefit managers in Washington, Gottlieb claimed that many entities are to blame for the skyrocketing drug prices patients are now facing, but that the FDA does [...]
President Donald Trump has recently released his budget plan, and many within the healthcare sector are disappointed to see that The Creating and Restoring Equal Access to Equivalent Samples Act, or CREATES Act for short, has been left out. This bill promises to increase competition and lower prescription drug prices, by eliminating abusive delay tactics [...]
As healthcare costs around the world continue to rise, regulators are working on developing solutions that will help provide reliable and more affordable treatment options for patients. One such solution is drug repurposing, which involves finding additional uses for already approved drug products. Because a commercially available drug has already been created, repurposing efforts involve [...]