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Jun
29
Sandeep Singh Dhillon
FDA Pilot to Sign Off on Low-Risk Digital Health Products Without Pre market Review – raps.org
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By Zachary Brennan

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Thursday announced an upcoming pilot program that would create a third-party certification program under which lower-risk digital health products could be marketed without FDA premarket review and higher-risk products could be marketed with a streamlined FDA review.

The pilot, part of a new approach to regulating digital health tools, would help to certify, according to Gottlieb, whether a company “consistently and reliably engages in high quality software design and testing (validation) and ongoing maintenance of its software products. Employing a unique pre-certification program for software as a medical device (SaMD) could reduce the time and cost of market entry for digital health technologies.”

FDA also will provide guidance clarifying its stance on products that contain multiple software functions and which currently fall outside FDA regulations.

“In addition, FDA will provide new guidance on other technologies that, although not addressed in the 21st Century Cures Act, present low enough risks that FDA does not intend to subject them to certain pre-market regulatory requirements,” Gottlieb wrote in FDA’s Voice Blog.

The push into digital health comes as Bakul Patel, ‎associate center director for digital health at FDA, recently told conference attendees that guidance related to software as a medical device, and a new dedicated unit to digital health are coming to FDA’s Center for Devices and Radiological Health (CDRH).

Gottlieb also noted that the postmarket collection of real-world data might be able to be used to support new and evolving product functions.

“For example, product developers could leverage real-world data gathered through the National Evaluation System for health Technology (NEST) to expedite market entry and subsequent expansion of indications more efficiently … The Medical Device Innovation Consortium (MDIC), a 501(c)(3) public-private partnership, is serving as an independent coordinating center that operates NEST. In the coming weeks, MDIC will announce the establishment of a Governing Committee for the NEST Coordinating Center comprised of stakeholder representatives of the ecosystem, such as patients, health care professionals, health care organizations, payers, industry, and government,” Gottlieb wrote.

NEST’s fully operational system is expected to come by the end of 2019.

Full article at http://www.raps.org/Regulatory-Focus/News/2017/06/15/27917/FDA-Pilot-to-Sign-Off-on-Low-Risk-Digital-Health-Products-Without-Premarket-Review/

Jun
13
Sandeep Singh Dhillon
‘Wow.’ In A First, FDA Requests An Opioid Be Pulled From The Market – Forbes
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By Matthew Herper

In a dramatic first, the Food and Drug Administration is requesting that a manufacturer, Endo Pharmaceuticals, remove an opioid drug, Opana ER, from the market because of its potential for causing abuse.

“We are facing an opioid epidemic–a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse,” said FDA Commissioner Scott Gottlieb in a prepared statement. “We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse.”

“Wow,” said Andrew Kolodny, the director of the Opioid Policy Research Collaborative at Brandeis University. “This is the first time I’ve seen FDA pull an opioid off the market.The question is will they stop here? Because there are some opioids where at least the upper doses should come off the market.”

Opioid overdoses killed 33,000 Americans in 2015, with half of those involving a prescription opioid. Overuse and abuse of the drugs have become a national crisis, and have also helped spur the use of illicit drugs like heroin.

Opana ER was approved in 2006 for patients who need round-the-clock pain relief. In 2012, Endo reformulated the drug to make it more resistant to physical and chemical tampering that makes it easier to abuse, for instance, by crushing and snorting. While the drug met the standards for approval, FDA says Endo never showed that the reformulation would reduce abuse, and Opana was never allowed to claim that it would in marketing materials.

Instead, the new formulation seemed to lead to a spike in intravenous use of Opana. Users would inject the new formulation, instead of crushing and snorting it. This change in behavior led to an HIV outbreak in Indiana. In a statement, Janet Woodcock, the head of the FDA’s Center for Drug Evaluation and Research, specifically attributed the decision to recommend Opana’s removal with that outbreak.

In March, an FDA advisory panel recommended that Opana should come off the market. But Kolodny, for one, was skeptical that it would happen. The FDA generally follows the recommendations, but not always. In 2013, the agency approved a new opioid, Zohydro, despite the fact that an advisory committee panel had recommended 11-2 that Zohydro should stay off the market.

Kolodny vocally opposed the selection of Gottlieb as FDA commissioner because of his ties to drug companies. But Kolodny now says he’s encouraged by this decision. “Maybe, like they say, only Nixon could go to China,” Kolodny says. “Maybe he will make the changes that have been needed for a long time.” The first other drug on Kolodny’s list? Subsys, the Binaca-like fentanyl spray made by Insys Therapeutics. It’s supposed to be used for cancer patients, but there is evidence it was marketed to people who did not have cancer. “That spray is like a lethal weapon,” Kolodny says.

Oxycontin was removed from the market when an abuse-resistant form became available, but that was done at the behest of manufacturer Purdue Pharma, not at the FDA’s request.

If a manufacturer chooses not to honor the FDA’s request to removing a product from the market, the agency can take legal action to force it to do so.

Last year, Opana ER generated sales of $159 million, down significantly from its peak of about $300 million. Endo has annual sales of $4 billion. In a statement, Endo said it is “evaluating the full range of potential options” and emphasized its “strong sense of responsibility” to patients. Shares in Endo traded down 13.6% to $11.90 in after-hours trading.

May
19
Sandeep Singh Dhillon
Up to one third of FDA drugs have severe safety issues – MIMS Malaysia
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Despite President Trump’s support for faster drug approvals, nearly a third of the drugs deemed safe and effective by the Food and Administration (FDA) are found to have major safety issues years after their approval, according to researchers at the Yale School of Medicine.

The study, led by Dr Joseph Ross, a Yale professor of general medicine and public health policy, hopes that regulators will be able to identify drugs that may have hidden health risks. This could allow regulators to reinforce reviews, increase post-market monitoring, or boost data sharing for certain drugs.

“We seem to have decided as a society that we want drugs reviewed faster,” said Ross. Hence, it is critically important “that we have a strong system in place to continually evaluate drugs and to communicate new safety concerns quickly and effectively,” he added.

Many approved drugs required a “black box” warning

“While the administration pushes for less regulation and faster approvals, those decisions have consequences,” said Ross. Previous studies by the Yale researchers gathered that the FDA approves drugs faster than its counterpart agency in Europe.

Among the 222 drugs approved by the agency between 2001 and 2010, 71 of them required a “black box” warning to indicate severe side effects or warranted a safety announcement about new risks to the public. In total, the FDA added 61 boxed warnings and issued 59 safety communications.

Furthermore, the agency withdrew three drugs, the anti-inflammatory drug valdecoxib, tegaserod maleate that treats irritable bowel syndrome and the psoriasis drug efalizumab. Valdecoxib and tegaserod maleate were withdrawn due to cardiovascular risks whereas efalizumab increased the risk of a rare and fatal brain infection.

“The majority of pivotal trials that form the basis for FDA approval enroll fewer than 1,000 patients with follow-up of six months or less, which may make it challenging to identify uncommon or long-term serious safety risks,” the study authors noted.

Additionally, the researchers found that the safety events arose within a median of 4.2 years, and the issues were more common among psychiatric drugs, biologic drugs and drugs approved near the regulatory deadline for approval.

“The high frequency of post-market safety events highlights the need for continuous monitoring of the safety of novel therapeutics throughout their life cycle.”

Financial implications of sped up approvals

When President Trump delivered his first speech to Congress, he addressed the FDA’s review process as “slow and burdensome”. He vowed to “slash the constraints” of the agency, though the FDA has been working more quickly than it has been throughout history.

However, a recent case on Alzheimer’s drugs shows the potential negative impact if the FDA adopts less-strict standards. The FDA’s decision on not to rush approval for Eli Lily’s experimental Alzheimer’s treatment, solanezumab, is said to have saved the American’s taxpayers USD100 billion over the past four years, as it was later found ineffective.

“The issue right now in the national conversation is this push to approve drugs faster and faster at all costs,” said researcher Dr Chana Sacks of Harvard Medical School and Brigham and Womens Hospital in Boston.

“The conversation usually focuses on the toxicity – the risks and benefits – of the drugs themselves. We wanted to think about the financial toxicity, which is very real, and what the financial implications might be of lowering standards,” she added.

In regards to the recent study, Angela Hoague, an FDA’s spokeswoman, said, “In general, the FDA does not comment on specific studies, but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health.” MIMS

May
11
Sandeep Singh Dhillon
Pfizer : FDA Grants BAVENCIO Approval For Common Type Of Advanced Bladder Cancer
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(RTTNews.com) – EMD Serono, the biopharmaceutical business of Merck KGaA (MKGAY.PK), and Pfizer Inc. ( PFE ) said that the US Food and Drug Administration has approved BAVENCIO (avelumab) Injection for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

BAVENCIO was previously granted accelerated approval from the FDA for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). These indications are approved under accelerated approval based on tumor response and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

In December 2015, Merck KGaA, Darmstadt, Germany and Pfizer announced the initiation of a Phase III multicenter, multinational, randomized, open-label, parallel-arm study (JAVELIN Bladder 100) of BAVENCIO plus best supportive care versus best supportive care alone as a maintenance treatment in patients with locally advanced or metastatic urothelial carcinoma whose disease did not progress after completion of first-line platinum-containing chemotherapy. This trial is currently enrolling patients.

Jan
8
Sandeep Singh Dhillon
The FDA Finally Tightened Rules for Livestock Antibiotics—But It’s Still Not Enough – Gizmodo.com
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On January 1, a set of long-awaited FDA rules went into effect that could mark a major shift in the agency’s approach to antibiotics for livestock animals. First, the new policies place an outright ban on the use of any antibiotics considered “medically important” to help animals gain weight. The rules also require that such drugs only be given to animals under the supervision of a veterinarian, when animals are actually ill.

The impetus here is the looming threat of so-called superbugs that have grown resistant to antibiotics. Critics have long warned that the widespread use of antibiotics in raising food animals has contributed to a superbug rise. Estimates suggest that somewhere around 70% of antibiotics are used in agriculture. That high percentage is due in large part to how those antibiotics are used—not to treat illness but to stave it off in dismal, disease-ridden conditions or to promote growth.

The new rules, known as Guidance for Industry #213, were published in December 2013, and rely on animal drug companies to make changes to antibiotic labeling in order to enforce them. Drug company compliance is technically voluntary, but drug companies agreed to comply, forcing agricultural producers and veterinarians to comply with labeling instructions by law. The FDA’s announcement this week was that drug makers have now implemented the new labels. Critics of rampant antibiotic use in animal agriculture are hopeful that this signals a very necessary sea change.

“The successful implementation of this guidance marks a fundamental shift in how antibiotics can be given to animals in the US and is indicative of the growing consensus that antibiotics should be used only when necessary and appropriate to protect animal health,” Pew Trusts antibiotics expert Karin Hoelzer wrote in a blog post.

But as Hoelzer and others have also pointed out, the new rules are still not enough, riddled with loopholes that could render them ineffective.

For one, preventative use of antibiotics, including medically important ones, is still permitted in livestock production, with the idea that it will be kept in check by veterinarian oversight. However, an analysis by Pew last fall found that one-third of antibiotics still approved for animals under the new rules are sold in ways could allow them to be misused. More than 140 drugs lacked dosage or duration specifications, meaning a food producer could still hypothetically, legally give an animal a prescribed drug for its entire life. Pew found other approved labels permitted drug use for conditions such as “weight maintenance” and the ambiguous “prevention of early mortality,” among other things.

The FDA has committed to addressing this problem, as the new rules indicate. But critics still contend those rules could be tougher, and that the agency could act faster. The Netherlands and Denmark, for example, have made it flat-out illegal to use antibiotics preventatively in the livestock sector.

An FDA report released just before Christmas revealed that sales of medically important antibiotics to the food animal sector has increased by 26 percent since 2009. In all likelihood, this problem is not going anywhere any time soon.

Oct
4
Sandeep Singh Dhillon
Antiseptic soaps often no better than plain water, says FDA – MIMS Malaysia
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The Food and Drug Administration in the United States has banned 19 chemicals that are commonly used in antibacterial soaps last week, as they failed to prove their safety and effectiveness at killing germs.

The ban focused on two ingredients – triclosan and triclocarban – that have been debated on regarding its safety for both humans and the environment. Limited research on animals indicates that hormone levels can be interfered with and the development of drug-resistant bacteria is also possible.

“We have no scientific evidence that they are any better than plain soap and water,” said Dr. Janet Woodcock, the Food and Drug Administration’s drug centre director.
Investigating triclosan since 40 years ago
As far back as 40 years ago, the U.S. Congress had already asked the FDA to investigate the benefits of triclosan as well as other antiseptic ingredients. However it only published its findings after the FDA was accused of delaying a decision on the safety of triclosan through a three-year legal battle with an environmental group, the Natural Resources Defense Council (NRDC).

“Consumers have waited a long time for this sensible safeguard,” said Mae Wu, an attorney of the NRDC. Many others have pushed for the publication of the findings, using research from the Centers for Disease Control and Prevention that found traces of triclosan in the urine of three-quarters of Americans tested for various chemicals.
However, the agency emphasises that many chemicals show up in urine without having any effect immediately but might do so in the long run.
Clinical data needed to support potential benefits
In 2013, a rule was proposed for manufacturers to provide the agency with proven additional data on the safety and effectiveness of certain chemicals present in over-the-counter consumer antibacterial washes.

Data should be from clinical studies proving that these products were indeed antibacterial and stood out from non-antibacterial washes in reducing transmission of bacteria. For the 19 chemicals, manufacturers did not manage to provide the necessary data and they have since been banned. In the case of triclosan, no human or animal studies have proven the drug as either safe or effective.

“Consumers may think antibacterial washes are more effective at preventing the spread of germs,” Dr. Woodcock said, adding, “In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term.”

Triclosan’s safety has been regularly questioned as most studies that involved laboratory animals showed changes in testosterone, estrogen and thyroid hormones. Researchers worry that if similar effects were in humans, it could interfere with the regulation of hormones and give rise to problems such as the risk of infertility, early puberty and even cancer. Some studies have also shown that the chemical contributes to liver toxicity and thyroid problems.

Apart from that, although the chemicals have been proven to kill some bacteria, experts worry that frequent use would inevitably develop superbugs that cannot be killed by antibiotics or other drugs. Although these risks do not pose an immediate danger, no potential benefits have been shown, said Dr. Theresa Michele, FDA division chief.
The American Cleaning Institute, a cleaning chemical association disputes the FDA statement and claims that “the FDA already has in its hands data that shows the safety and effectiveness of antibacterial soaps.” The FDA has no comment to that statement.

Three additional chemicals – benzalkonium chloride, benzethonium chrloride and chloroxylenol – are still present in antibacterial products and have been give one more year to collect data.

This ruling does not apply to hand sanitisers as most use alcohol instead of antibacterial chemicals. However, the FDA is now undertaking a sweeping reevaluation of soaps and washes used by consumers and health professionals.

Dec
1
ragupathyrenganathan
Return to: PBR Home | Regulatory Affairs Regulatory Affairs News FDA declines to approve expanded use of Bristol-Myers Squibb’s Opdivo drug
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Nov
17
ragupathyrenganathan
FDA’s ‘breakthrough’ endorsement carries real weight with the public
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Nov
13
ragupathyrenganathan
FDA clears Glenmark’s generic skin infections cream
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Nov
3
ragupathyrenganathan
FDA cites Pfizer for shortfalls at Chinese manufacturing plant – Courtesy Fierce Pharma
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