Faced With A Rising Tide Of Drug Shortages, FDA Considers Quality Rating System For Manufacturing Facilities
The system, the agency hopes, would encourage facilities to avoid quality missteps that can often lead to shortages. In other pharmaceutical news: drug pricing legislation, a vote on pre-term birth medication, immunotherapy drugs, and more.
Stat:
FDA Considers Rating Manufacturing Facilities To Fight Drug Shortages
Seeking to reduce a rising tide of shortages, the Food and Drug Administration is considering the idea of creating a system to rate manufacturing facilities run by drug makers. The hope is that customers — notably, group purchasing organizations for hospitals, but also consumers — would reward drug companies that consistently make medicines that conform to quality standards. In doing so, this could yield steady sales that would, in turn, provide incentives for further investment in facilities and, hopefully, lessen the likelihood of the sorts of quality issues that lead to shortages. (Silverman, 10/28)
CQ:
House Takes Up Bipartisan Drug Price, Vaping Bills
The House on Monday is poised to pass a handful of modest bipartisan bills related to drug prices and e-cigarettes, as Democrats negotiate among themselves on more ambitious actions to address the high-profile issues. The chamber will take up two drug pricing bills, another bill (HR 3942) that will require age verification for online e-cigarette sales, and three other bills that would extend health workforce and education programs. (Siddons, 10/28)
Politico Pro:
House Passes PBM Transparency Bills
The House today unanimously passed a bill that would require more public disclosure of the discounts drug companies give to pharmacy benefit managers. Rep. Abigail Spanberger's bill, H.R. 2115 (116), approved 403-0, would require PBMs to report to HHS their aggregate rebates, discounts and other price concessions received on drugs from manufacturers. (Karlin-Smith, 10/28)
Stat:
Will FDA Panel Say A Drug To Prevent Premature Birth Can Stay Available?
A controversial treatment for preventing premature births will be reviewed by a Food and Drug Administration advisory panel on Tuesday amid intensifying debate over whether the medication, called Makena, should remain on the market. The panel is set to review a required followup study that found the medicine was not effective, a troublesome development given that Makena has become the standard of care since winning FDA approval nine years ago. (Silverman, 10/28)
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AstraZeneca Aims To Carve Into Merck’s Immunotherapy Dominance
AstraZeneca said Monday that its two immunotherapy cancer drugs, when combined with chemotherapy, slowed the progression of late-stage non-small cell lung cancer compared to chemotherapy alone. The result comes just six days after Bristol-Myers Squibb reported similar findings with its own immunotherapy drugs and will likely lead to speculation as to whether Merck can hold onto its dominance in lung cancer with its treatment, Keytruda. Both data releases included only preliminary and incomplete data for investors, with full scientific results to follow in the future. (Herper, 10/28)
Bloomberg:
AstraZeneca’s Oft-Failed Cancer Combo Succeeds In Lung Trial
AstraZeneca Plc’s novel combination of cancer treatments succeeded in a final-stage study, showing utility against lung tumors after a string of failures. Results from the trial of tremelimumab in combination with Imfinzi, an approved cancer drug, and standard chemotherapy showed a statistically significant and meaningful improvement in a measure of cancer progression, AstraZeneca said in a statement. (Lauerman, 10/28)
Kaiser Health News:
Moved Overseas For School, Stayed For Insulin
Every now and then, Katie West considers returning to the United States. She moved to Germany for graduate school three years ago and now works as a health systems researcher in Hamburg. Her family is an ocean away. Then she remembers why she stays. West, 30, has had Type 1 diabetes since she was 3. Back in Seattle, where she used to live, she typically paid $70 per month for insulin and another $130 for pump supplies. That was a relative steal in the U.S., made possible by her excellent health insurance, which she got through her employer. But still, it was a financial strain. (Luthra, 10/29)
