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The federal government...approved a device made by a private company...that will allow the first domestic production of a medical imaging isotope...a move the government said would enhance national security by reducing the need to transport weapons-grade uranium...The Food and Drug Administration granted the approval to NorthStar Medical Radioisotopes, which said it would begin delivering systems to make technetium-99...the most common isotope in medicine and is used in 40,000 procedures a day in the United States...consumers have long had to depend on a complicated and risky supply chain for the materials...The current process involves shipping weapons-grade, or highly enriched, uranium from the United States to research reactors in Australia, South Africa and Europe where it is irradiated to make molybdenum-99, which decays into technetium-99..."This is a win for our national security," said Peter Hanlon, an official with the National Nuclear Security Administration office of material management and minimization...

Federal regulators said Wednesday that they are cracking down on marketers and distributors selling a dozen products that “illegally” claimed to treat or cure opioid addiction and withdrawal...In letters sent earlier this month, the Food and Drug Administration and the Federal Trade Commission cited products that target people desperate to find relief from their addictions. They include “Opiate Freedom 5-Pack,” “CalmSupport” and “Soothedrawal.” Most of the 12 items are marketed as dietary supplements, while two are homeopathic remedies, the FDA said...The letters are the latest effort to combat what FDA Commissioner Scott Gottlieb called a “proliferation” of unapproved products claiming to treat opioid addiction. In a statement, Gottlieb excoriated “unscrupulous vendors who are trying to capitalize on the epidemic by taking advantage of consumers and selling products with baseless claims.”

The FDA is proposing a new risk-based enforcement approach to homeopathic drug products. Among the targets: products marketed for serious diseases without showing clinical benefits, products that contain potentially harmful ingredients, and products that don’t meet current good manufacturing practices...homeopathic drug products are subject to the same requirements related to approval, adulteration, and misbranding as any other drug product. However, prescription and nonprescription drug products labeled as homeopathic have been manufactured and distributed without FDA approval under the agency’s enforcement policies since 1988...“In recent years, we’ve seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer,” said FDA Commissioner Scott Gottlieb...“In many cases, people may be placing their trust and money in therapies that may bring little to no benefit in combating serious ailments, or worse—that may cause significant and even irreparable harm because the products are poorly manufactured, or contain active ingredients that aren’t adequately tested or disclosed to patients...The FDA intends to focus its enforcement authorities on the following kinds of products:

• Products with reported safety concerns
• Products that contain or claim to contain ingredients associated with potentially significant safety concerns
• Products for routes of administration other than oral and topical
• Products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions
• Products for vulnerable populations
• Products that do not meet standards of quality, strength, or purity as required under the law

It is shaping up to be a bumper year for drug approvals, with U.S. officials clearing twice as many novel medicines as in 2016, yet returns on research investment at leading pharmaceutical companies are down...In fact, projected returns at 12 of the world’s top drugmakers have fallen to an eight-year low of only 3.2 percent...The disconnect reflects the rising cost of developing new drugs, meager peak sales expectations for individual products and the fact that younger biotechnology companies are accounting for a growing proportion of new products...So far this year, the Food and Drug Administration...has approved 41 novel drugs compared with 22 for the whole of 2016...It’s been a great year for approvals in 2017...But for the giants of the pharma world...things are not so rosy. This decade has seen shrinking profitability in their research labs, with the average internal rate of return down sharply from 10.1 percent in 2010 to 3.2 percent this year...A separate group of four large biotech companies are projected to enjoy an IRR nearly four times higher at 11.9 percent. The calculations are based on long-term sales forecasts...The biotech companies are seeing more success...biotechs typically had a leaner cost structure...

...Food and Drug Administration is asking manufacturers of a common opioid medicine to change the way the drug is packaged, as part of efforts to deter its abuse amid an opioid epidemic...The FDA said...it sent letters to manufacturers of diarrhea medicine loperamide, asking them to ensure that packages contain only a limited amount of the drug that is appropriate for use for short-term diarrhea...The agency wants to eliminate the large bottles in which loperamide is often sold because the abuse of the drug requires such large quantities.

Confusion and concerns over portions of a tobacco-related final rule have pushed the US Food and Drug Administration to delay implementation of the sections dealing with the types of evidence FDA may consider to determine how a manufacturer intends for its medical product to be used...This is a determination that can have significant implications for, among other things, how manufacturers communicate about and promote their products. How we determine intended use is an important issue that touches many fundamental aspects of the FDA’s work...FDA is seeking comments on the proposal to delay...effective date of the portion of the rule related to intended use of medical products, though the tobacco-related portions of the final rule will go into effect...At issue is how the initially proposed rule sought to remove a sentence, which FDA Law Blog last February called "the famous 'knowledge' sentence: 'But if a manufacturer knows, or has knowledge of facts that would give him notice, that a [drug or device] introduced into interstate commerce...is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a drug/device which accords with such other uses to which the article is to be put.'"...But the final rule did not remove the sentence and instead amended it with new language that angered industry groups, which called the move "a new and unsupported legal standard."

With a new administrator at the helm, the U.S. Food and Drug Administration took steps toward regulating decision support, software-as-a-medical-device, mobile tech in clinical trials and more...the FDA had a full plate in 2017 as it sought to revise its regulatory processes for the shifting healthcare landscape...the new guard already had announced and implemented a firm-focused pre-certification program, released new guidances addressing provisions of 2016's 21st Century Cures Act, and outlined a handful of other ongoing initiatives that are sure to impact the digital health industry. Here's a rundown of the agency's actions and announcements during 2017.

• New leadership, new approaches
  ...a plan that included clear language on which devices the agency would look to regulate, an app regulation strategy involving postmarket data collection, and other idea designed to streamline the approval process...FDA opened up applications for a pilot of a firm-focused digital health pre-certification program...nine companies selected to participate: Apple, Samsung, Verily, Pear Therapeutics, Tidepool, Phosphorus, Fitbit, Roche, and Johnson & Johnson...draft of the long-awaited and somewhat controversial guidance on clinical decision support, which laid out the forms of clinical decision support that would or wouldn't be regulated based on the degree of human involvement (as opposed to risk)...draft guidance describing the FDA's new Breakthrough Devices Program...would supersede the Expedited Access Pathway and aims to push novel technologies presenting a significant improvement over status quo through the clearance process more quickly.

• FDA shifts toward digital, patient feedback
  ...the Clinical Trials Transformation Initiative – a public-private partnership of pharma companies, academics, and regulators including the FDA – released new endpoint recommendations for the use of mobile technologies in clinical trials... The guidelines, meant to be the first in a series of such documents, included suggestions for study designers when selecting novel endpoints, practical approaches when developing these endpoints...

A risk-based approach to inspection regulations could result in increased audits of more complex manufacturing sites, the FDA says...The final rule...revises time of inspection requirements and removes the duties of inspector requirements, both contained in section 600​ of the Code of Federal Regulations (entitled ‘Biological Products: General’)...It will affect how often the Food and Drug Administration is inspecting certain facilities and implement a risk-based schedule replacing...the biennial inspection requirement for drug and biological product establishments required in the Federal Food Drug and Cosmetic Act ​ and aligning the requirements with 2012’s Food and Drug Administration Safety and Innovation Act ...“This change clarifies the FDA’s flexibility under FDASIA to inspect facilities either more or less frequently, according to the potential risk the establishment’s operations present, without diminishing public health protections,”...According to Commissioner Scott Gottlieb, the ruling is part of efforts to modernise the FDA’s regulations, remove inefficient policies and reduce costs.

U.S. drug approvals hit a 21-year high in 2017, with 46 novel medicines winning a green light -- more than double the previous year -- while the figure also rose...in the European Union...recommended 92 new drugs including generics, up from 81...Yet the world’s biggest drugmakers saw average returns on their research and development spending fall, reflecting more competitive pressures and the growing share of new products now coming from younger biotech companies...projected returns at 12 of the world’s top drugmakers were at an eight-year low of only 3.2 percent...

The Food and Drug Administration has issued guidance on 3D printing and the role it plays in manufacturing healthcare products...While the guidance focuses largely on medical devices, Commissioner Scott Gottlieb acknowledged in a Monday statement that the innovative technology also holds the potential to disrupt drug development. Already, the agency has approved one medicine crafted with 3D printers, Aprecia Pharmaceutical Co.’s Spritam..."This is likely just the tip of the iceberg given the exponential growth of innovative research in this field," Gottlieb said, referring to the 3D-printed products on the market. "We envision that burn patients in the near future will be treated with their own new skin cells that are 3D printed directly onto their burn wounds. Further down the road, there is the potential for this same technology to eventually be used to develop replacement organs."...The promise of 3D printing, however, could spark new innovation and invention in how drugs, and the devices that deliver them, are formulated and made. In response, the FDA is moving to stay ahead of the technology's advances....