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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.”

New pilot program to evaluate disclosure of clinical study reports...As part of its efforts to enhance transparency around drug approval decisions, the FDA is exploring ways it can continue to build on its obligation to share information…The agency is especially focused on information that can improve patient care and better inform providers about the products they prescribe. One place where it is evaluating how it can release information that may better inform scientists, providers, and patients is clinical study reports (CSRs)...The FDA has launched a pilot program to evaluate whether disclosing certain information included within CSRs following approval of an NDA improves public access to drug approval information...The FDA intends to post the parts of the CSRs that were most important to the agency’s assessment of the safety and efficacy of the drug, specifically, the study report body, the protocol and amendments, and the statistical analysis plan for each of the participating product’s pivotal studies...

DOJ is investigating drug-makers’ financial support of patient-assistance charities...A U.S. charity offering assistance to patients for their out-of-pocket drug costs has sued the federal government over restrictions on its ability to communicate with drug-makers who donate to it...The charity, Patient Services, Inc., filed the lawsuit in federal court in Richmond, Virginia. It comes amid a Justice Department investigation into drug-makers’ financial support of patient-assistance charities...Drug-makers are prohibited from subsidizing copayments for patients enrolled in Medicare, but they may donate to nonprofits providing copay assistance as long as the charities are independent. Amid increased attention to rising drug prices, concern has arisen that drug-makers’ donations to such charities may be contributing to price inflation.

With $200 billion lost to counterfeit drugs annually and patient safety issues, a chain-of-custody log that blockchain could enable holds promise...Blockchain has the potential to transform healthcare in general and the pharmacy supply chain in particular...The distributed ledger technology could offer legislative, logistical and patient safety benefits for pharmaceutical supply chain management. From a regulatory perspective in the United States, blockchain technological and structural capabilities, in fact, extraordinarily map to the key requirements of the Drug Supply Chain Security Act...The DSCSA outlines a 10-year timeframe that will require elements including medication track-and-trace, product verification and notification of stakeholders about illegitimate drugs. A shared ledger of information to enable each of these steps is a foundational aspect of blockchain technology...“Logistically, blockchain aligns well with federal efforts like the National Strategy for Global Chain Security,”...“One of the most promising benefits of blockchain from a patient safety perspective is to help stem the tide of the so-called SSFFC medicines – substandard, spurious, falsely labeled, falsified and counterfeit – that continue to plague the pharmaceutical supply chain.”

Shares of generic-drug makers including Mylan NV and Teva Pharmaceutical Industries Ltd. fell after the Justice Department’s antitrust division said it might sue them for damages in a price-fixing probe...If taxpayers were overcharged because drugmakers conspired to raise the price of drugs, the Justice Department will consider suing to seek damages, Makan Delrahim, the division’s chief, said...“To the extent that taxpayers have had to pay that bill, I think the taxpayers should recover,” he said. “We will get involved on the civil side and recover damages for the U.S. government.”...Mylan dropped as much as 3.1 percent after the comments and traded down 0.6 percent to $46.25 at 1:37 p.m. in New York. Teva’s U.S. depositary receipts dropped as much as 2.8 percent and were down 1.5 percent to $20.41 and Endo International Plc fell 5.6 percent to $6.92...The three drugmakers are among more than a dozen companies targeted by the Justice Department and state attorneys general in a multi-year investigation into generic drug price-fixing. So far, the probe has led to guilty pleas from two former executives of Heritage Pharmaceuticals...

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."

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

The warning letter was sent late last month to Delta Laboratories of New South Wales, Australia, after the FDA put all of the company’s human and animal drugs and antibiotics on its import alerts list in September...According to the FDA, Delta didn’t fully investigate discrepancies, including signs that might have indicated microbial contamination and didn’t have the processes needed to assure products would remain stable during storage and through the expiration date. It also noted the quality assurance unit didn’t have the necessary authority to make sure those kinds of standards are met...Senior management stated that your firm has struggled with manufacturing this drug product, and that you were still conducting research to gain better product and process understanding. Although you acknowledged a lack of understanding to assure consistent quality, you still commercially distributed drug products to consumers...The agency strongly recommended that Delta hire a consultant if intends to continue to producing products for the U.S.

Nevada's new opioid prescription law is only days old but doctors already are worried about how it might be implemented...physicians, lawyers and others expressed concerns this week to the state medical and dental boards over draft disciplinary rules for doctors who write improper prescriptions for pain medications...Under the proposed rules, doctors who violate the new law five times would lose their licenses. The threshold on losing a license would be reduced to three violations by 2020...Several doctors who attended the meeting say the proposed rules don't specify the exact conduct that could lead to penalties or the loss of medical licenses...The doctors voiced concerns that they could be punished for relatively minor mistakes or employee errors.

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...