When the U.S. Congress resumes next week, its top priority will be the passage of a massive budget bill that once again includes long-promised – or threatened, depending on a person’s perspective – provisions intended to bring down prescription drug prices.
In a bid to bring more drug manufacturing back to the U.S. and to ensure an adequate supply of essential medicines, even in public health emergencies, the U.S. Department of Health and Human Services is forming a public-private consortium on advanced manufacturing and the onshoring of domestic production.
Once upon a time in an age before the Internet, all things digital and even Hatch-Waxman, the FDA worked in its corner of the government approving drugs and therapeutic equivalents with little fanfare or transparency. Its decisions were duly recorded on paper and filed away. With the files located only at the agency, pharmacies across the country were left to wonder about which drugs could be substituted for another. Their recourse was to pick up the phone and pay for a long-distance call to the FDA every time a question arose. To reduce the number of phone calls it was getting, the FDA printed out a list of approved drugs with their equivalents and sent it to the pharmacies. The year was 1980, and the month was October. Going with the season, the FDA slapped an orange paper cover on the listing, giving birth to the Orange Book.
The governor’s signature brought California a step closer to realizing state officials’ dream of having their own generic and biosimilar drug label. In signing the California Affordable Drug Manufacturing Act into law Sept. 28, Gov. Gavin Newsom touted the legislation as a way to break down market barriers to affordable prescription drug prices. “Our bill will help inject competition back into the generic drug marketplace – taking pricing power away from big pharmaceutical companies and returning it to consumers,” he said.
In March, when a district court ruled in favor of two ANDA filers in Amarin Corp. plc’s patent litigation case regarding its fish oil cardiovascular therapy franchise, Vascepa (icosapent ethyl), CEO John Thero said an appeal was a strong possibility.
Nearly 40 years on, the generic drug market is often lauded as an American success story. But a closer inspection reveals such back-patting ignores the potential for serious public health risks caused by ongoing shortages in the generic drug supply. It also ignores quality issues and lingering physician and patient doubts about generics, especially those made in other countries.
LONDON – The industry has hit out at a proposal by the U.K.'s opposition Labour party to create a state-owned generic drugs company to supply the National Health Service and to force companies to cut the cost of expensive proprietary products.
Calling the tie "magic," Pfizer Inc. CEO Albert Bourla defended his firm's decision to spin off its Upjohn unit and merge in an all-stock deal with Mylan N.V., creating a new entity to be named later with pro forma revenues as high as $20 billion. "We have a commercial footprint that is very much focused on China, on emerging markets," he said, which will help Mylan.
FDA clearance of Retrophin Inc.'s enteric-coated (EC) version of Thiola (tiopronin) 100-mg and 300-mg tablets for cystinuria – a rare, inherited disorder that causes levels of cystine to build up in urine, which leads to recurrent kidney stones – gave patients new dosing flexibility and set Wall Street abuzz about options for the San Diego-based firm as well.
