FDU Backlog on generics under attack- Clinton to FAST TRACK!I posted this under a different title and only got a star. So I figure someone wanted me to repost. So here it is! Now, please star properly! LOL ;-) You'll confuse novices with your starwars! ;-)
https://www.managedhealthcareconnect.com/content/fda-generic-approval-backlog-under-fire-clinton-plan-targets-drug-prices DRUG PRICES
Recent price hikes for prescription drugs have led to increased scrutiny from lawmakers and patients, including a plan released by Presidential candidate Hillary Clinton to protect consumers from increased prices, drawing the FDA’s lengthy list of generic drug applications awaiting approval into the spotlight.
Following the sudden price increase of Mylan’s EpiPen, Hillary Clinton proposed a plan to investigate and respond to price hikes of older drugs with limited competition. The plane proposed an investigative board, which would determine if price increases are unjustified. Furthermore, if this panel determines that a price hike is unwarranted, the pharmaceutical companies could receive fines or increased rebate penalties. Clinton’s plan states that the cost of fines would support new programs to make lower-cost alternatives and increase approval of competing treatments.
In an effort to keep the costs down, Clinton’s plan would allow for the emergency purchase of alternative treatment options. According to Clinton’s campaign, between 2008 and 2015, companies increased the price of almost 400 generic drugs more than 1,000%. Lawmakers proposed that more generic drugs would offer cheaper alternative therapies as a solution to current drug price surges in the US.
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However, the backlog of generic drug applications at the FDA stretched roughly almost 4 years. According to the Generic Pharmaceutical Association, as of July 1, 2016, the FDA had 4036 generic drug applications awaiting approval, and it is estimated to take 47 months to approve the backlog.
The generic drug backlog is a recurring problem facing the FDA. In 2012, there was a backlog of 2868 generic drugs awaiting approval. The FDA claimed they would approve 90% of the 2012 applications by 2017. The FDA charged fees to generic drug companies and hired 1000 employees; however, only 1551 generics have been approved in that time. According to the data, only about half of the backlogged generics have been approved since 2012.
The number of generic drug applications have tripled from 2002 to 2012.
In an effort to approve generic drug applications quicker and lower costs similar to those suggested in Clinton’s plan, the FDA stated that, “Additional resources will enable the Agency to reduce a current backlog of pending applications, cut the average time required to review generic drug applications for safety, and increase risk-based inspections.” ---Julie Gould
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