- Faster registration, more transparency punctuate new HHS clinical trial final rule (medcitynews.com)
The Department of Health and Human Services issued its final rule on submitting registration and summary results to clinicaltrials.gov. In a nutshell, the new guidelines define which clinical trials must be registered and when, how results should be reported (and when) and potential penalties for non-compliance...The rule seeks to clarify the Food and Drug Administration Amendments Act of 2007, which left significant room for interpretation...Enhancing access to clinical trial information means more useful data for patients and scientists. People who have exhausted their treatment options may have more access to experimental therapies. Scientists can build on trial success and avoid failures...Overall, the rule is getting good reviews for its effort to increase transparency and respond to systemic flaws...It reflects that we have this learning healthcare system, which is what we want...We want laws that learn, that take feedback and are able to understand what is working and what is not working and be amended in order to work better...
- China Drug Sales to the U.S. Grow Despite Safety Concerns at Home (bloomberg.com)
Chinese drugs and pharmaceutical ingredients are found in medicine cabinets as far away as New York and Chicago, and the country’s exports of pharmaceutical products and health supplements worldwide jumped 3 percent to $56 billion last year...Yet even as China’s drug industry has grown in global stature, so have questions about the safety of its products...about 700 Chinese firms were told by regulators in China to review their pending applications to sell new drugs and voluntarily withdraw any that were false or incomplete. Within months, about 75 percent had been retracted by the manufacturers or rejected by Chinese officials...Among those were some medicines that were separately approved for sale in the U.S. by the Food and Drug Administration. Some of the companies say their data in China were flawed because of faulty information by local research firms...
- The FDA just greenlit releasing mutant Zika-killing mosquitoes in Florida (fusion.net)Spraying Begins in Miami to Combat the Zika Virus (nytimes.com)Zika in the United States, explained in 9 maps (vox.com)
...the Food and Drug Administration gave the okay to a field trial that would release genetically modified Zika-killing mosquitoes in the Florida Keys...the FDA released a final environmental assessment of the trial, finding that it “will not have significant impacts on the environment.” The project, led by Oxitec, a biotech company that focuses on insect control, calls for the release of thousands of genetically engineered male Aedes aegypti mosquitoes. The lab insects are bred so that over time they could kill off much of the local mosquito population by passing on a gene fatal to any offspring they have with wild females...The FDA’s okay is a major step forward toward a U.S. implementation of the technology at a time of much concern over the spread of Zika in the U.S. after cases in Florida...
- Facing Cancer Drug Shortage, U.S. Relies on Banned Chinese Plant (bloomberg.com)
Last September, U.S. regulators faced a dilemma: whether to allow importation of drug ingredients from a Chinese factory (Zhejiang Hisun Pharmaceutical Co.) with a history of poor quality controls, or face shortages of treatments for American cancer patients...Food and Drug Administration inspectors had uncovered what the agency later called “broad data manipulation” at the factory, located in Taizhou....Information about the potency and purity of some product batches had been deleted, making it difficult to investigate a significant increase in customer complaints...The agency issued an indefinite ban on the factory...one of China’s leading exporters of pharmaceuticals products. Yet to avoid possible shortages of drugs, the FDA allowed the plant continue exporting about 15 ingredients for use in finished drugs in the U.S., including nine key cancer medicine components. Hisun says that it takes quality seriously and has complied with requirements.
- FDA staff flags concerns about Pfizer’s quit-smoking drug study (reuters.com)
Pfizer Inc's trial data on Chantix, a drug to help people quit smoking, failed to impress U.S. Food and Drug Administration scientists, in a blow to the company's attempts to have a serious warning removed from the drug's label...The FDA...expressed concerns about the collection and interpretation of data from a post-marketing study on the controversial drug...Pfizer has been trying to have the "black box" warning - which warns of psychiatric risks including suicidal thoughts, hostility and agitation - removed from the drug's label...the study...compared Chantix or...Zyban with a placebo or a nicotine patch in smokers with and without a history of psychiatric disorders, showed that the drug did not significantly increase the incidence of serious neuropsychiatric side-effects...FDA staff disputed the results, flagging inconsistencies in data collection and characterization of the severity of some side-effects...
- FDA to hold long-awaited meeting to review off-label marketing (statnews.com)
After years of anticipation, the Food and Drug Administration will hold a public, two-day meeting in November to review the extent to which so-called off-label information about medicines may be disseminated to physicians...the FDA has taken a firm stance toward the issue. A key concern is that public health could be jeopardized if a company were to distribute information about an unapproved use that had not been proven to be safe and effective, a standard for regulatory approval...drug makers have argued that conveying certain types of information is protected by the First Amendment...drug makers and their supporters have grown impatient and fear that various court rulings might become a de facto standard. Last winter, an independent review panel was floated as a way to address the issue. Last May, two lawmakers accused the Department of Health and Human Services of delaying new rules and issued a draft bill that would allow companies to market products for unapproved uses...
- Drugmakers Split on Whether to Include Interchangeability Statement in Biosimilar Labels (raps.org)
Drug, biologic and biosimilar companies’ comments on Food and Drug Administration draft guidance on biosimilar labeling reveals a major split between those who do and do not want a statement on a biosimilar’s interchangeability status on each new product's label...FDA has still yet to release its guidance on what interchangeability means, and as FDA has not found any biosimilar to be interchangeable with its reference product…
- Amgen says it...believes a biosimilar label should include a summary of the clinical data, including immunogenicity data, used to demonstrate biosimilarity or interchangeability…
- Pfizer said...biosimilars should not be labeled "as though they were small molecule generic drugs" and that it "recommends that biosimilar labeling include a statement reflecting whether interchangeability has been assessed."
- Merck & Co...says "that a single blanket approach applicable to all biosimilar products is not appropriate, and may cause unnecessary confusion among stakeholders."...recommends that rather than using such blanket statements, FDA take a risk-based approach for each biosimilar…
- Boehringer Ingelheim says that it "does not agree that a biosimilar label needs to include a ‘biosimilarity statement,’...Such information is not ‘essential scientific information needed by health care practitioners for the safe and effective use of a drug.’
- Sandoz...says... "It is self-evident that the very act of highlighting the indications that are extrapolated is being proposed by some groups in order to raise doubts as to the safety and efficacy of the biosimilar for those indications, and perhaps to also imply inferiority of biosimilars across the board.
- Compounding Pharmacies: Safety Blind Spot (morningconsult.com)
To protect patients, pharmaceutical manufacturers must monitor any adverse events we hear about with respect to the drugs we produce and report those adverse events to the Food and Drug Administration, as required by law...Developing and maintaining an accurate safety profile of a product is a joint responsibility between the manufacturer of the product, the FDA and consumers...As noted, reporting of adverse events to the FDA is a critical component of the patient safety protection system...While some compounding pharmacy adverse events are now haphazardly reported — FDA just last week sent warning letters to drug compounding pharmacies in Tennessee and Virginia following reports — there is a giant gap in that system that may put patients at risk —adverse events with respect to drugs made by compounding pharmacies are generally not required to be reported to anyone...Regardless of how quickly states work to improve their oversight of sterile compounding, an immediate step should be to require reporting of adverse events. If states do not act to require this kind of reporting, Congress should step in and mandate it. Until then, patient safety is at risk.
- FDA Starts Showing Its Plans for Oversight of Pharmacy Compounding (ashp.org)
This spring and summer, FDA revealed in several guidance documents what the agency thinks pharmacy compounding should look like now that the relevant provisions in federal law are firmly in place and the agency has a budget for oversight...Some of FDA's ideas, if incorporated into the final versions of the guidances, could be challenging for hospitals and health systems to implement…as hospitals continue to affiliate or form multihospital systems...a plan to centralize compounding activities may need to be reconsidered.
- Guidances, not regulations
- Limits on anticipatory compounding.
- Geographic limit on distribution.
- Address-dependent facility definition.
- No copycats of commercially available products.
- FDA enhances warnings on group of strong antibiotics (reuters.com)FDA updates warnings for fluoroquinolone antibiotics (fda.gov)
The...Food and Drug Administration has enhanced warnings of side effects of a group of strong antibiotics used to treat a variety of respiratory and urinary tract infections and limited their use to patients with no alternatives...fluoroquinolones include Johnson & Johnson's Levaquin, Bayer's Cipro extended-release tablets and Merck Inc's Avelox....FDA added a box warning to the antibiotics in July 2008 to inform users about the increased risk of tendinitis in which the tissue connecting muscle to bone becomes inflamed.