Home Tags Posts tagged with "FDA"

FDA

The Trump administration’s budget proposal for the new fiscal year includes a plan that would spin out the Center for Tobacco Products as a separate agency from the Food and Drug Administration, according to The Hill. Presently, the FDA regulates all tobacco products in the United States along with foods, prescription drugs and over-the-counter medications.

The Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA the authority to regulate tobacco products. In the years since, however, the nature of the tobacco industry was transformed by the advent of vaping products and e liquid. While the total number of tobacco products on the market once numbered in the dozens – and most of those were grandfathered by the Tobacco Control Act – there are now hundreds of vaping products on U.S. shelves being sold without approval, and the FDA needs to receive and begin processing pre-market applications for those products by May.

The FDA has repeatedly stated that it lacks the resources to promptly process pre-market applications for vaping products while handling all of its other duties.

Why Has the Trump Administration Proposed a New Tobacco Control Agency?

According to the administration’s budget proposal, the reasons for spinning out the Center for Tobacco Products into a separate agency are twofold.

  • The creators of the Tobacco Control Act didn’t envision how the tobacco industry would change in the future. Vaping is an extremely complex issue, and a separate agency would have its own budget and resources for handling that.
  • The core mission of the FDA is to regulate and ensure the safety of foods and medications. When one really thinks about it, the addition of tobacco product regulation to the FDA’s existing duties isn’t entirely logical; tobacco products don’t promote health. In the words of White House Domestic Policy Council head Joe Grogan, tobacco products have “no redeeming qualities,” and tasking the FDA with regulating those products is a “huge waste of time” for an agency created for the promotion of public health.

How Has Vaping Increased the Complexity of Tobacco Regulation?

When the Family Smoking Prevention and Tobacco Control Act of 2009 was signed into law by President Obama, the tobacco industry was very different from today. No one could have anticipated how the industry would change in the coming decade. The reasons for the complexity surrounding tobacco regulation in 2020 are as follows:

  • The Tobacco Control Act established a grandfather date of 2007 for existing tobacco products, allowing those products to remain on the market with a handful of changes:
    • Descriptive terms like “Light” and “Ultra-Light” were no longer allowed because those terms implied that those products were less harmful.
    • Flavored cigarettes – apart from menthol – were no longer allowed.
  • Companies couldn’t bring new tobacco products to the market without first submitting applications to the FDA proving that those products were beneficial to public health and wouldn’t encourage new nicotine uptake. Effectively, the law made it illegal to release a new combustible cigarette brand in the United States; no combustible cigarette benefits public health.
  • Vaping didn’t achieve mainstream popularity until after the signing of the Tobacco Control Act.
  • In 2016, the FDA announced that it deemed vaping products to be tobacco products and would regulate them as such under the provisions of the Tobacco Control Act.
  • No vaping product currently sold in the United States was available in 2007. Therefore, every vaping product on the market is an unapproved “new tobacco product” requiring a pre-market application.

When the Tobacco Control Act was signed into law, lawmakers expected that the FDA would receive new tobacco product applications only rarely. Instead, the agency may have to process hundreds of new product applications in 2020. It’s an enormous burden that the FDA isn’t equipped to handle.

Expert Opinions on Trump’s Tobacco Control Proposal

Some experts believe that the FDA is already doing a well enough job of regulating tobacco and vaping products and have applauded the agency’s efforts to ramp up its capabilities in advance of the May 2020 pre-market application deadline for vaping products. Recently departed FDA head Scott Gottlieb – a vocal proponent of vaping’s potential as an agent for tobacco harm reduction – stated that he found tobacco regulation an extremely productive use of his time when he was the agency’s commissioner.

Some also believe that keeping the authority to regulate tobacco products within the FDA is the right decision because the agency is theoretically insulated from outside political pressure. Creating a separate agency for tobacco regulation, those people say, gives tobacco companies a potential opportunity to meddle.

At the time of writing, no one from the vaping industry has commented about the budget proposal. The reason for the silence from the industry may be the fact that the organizational realignment wouldn’t fundamentally change anything about the way in which the government regulates the vaping industry. Pre-market applications for all vaping products will still be due by May 2020, and those applications will still be too expensive for most of the industry’s small businesses to put together. The realignment wouldn’t solve the core problem with vaping product regulations in the United States: Applying the same rules to both vaping products and tobacco products simply doesn’t make sense.

Will the Trump Administration’s Budget Proposal Pass?

The idea of creating a new government agency for tobacco product regulation is just one section of the Trump administration’s proposed $4.8 trillion budget for the upcoming fiscal year, and the budget requires approval from the House of Representatives and the Senate before it can be enacted. Since the Democratic party controls the House of Representatives, it is extremely unlikely that the proposed budget will be passed in its current form. In particular, the idea of creating a new tobacco control agency seems to have little support among lawmakers.

The Tobacco Control Act presents an additional challenge in the implementation of the Trump administration’s budget proposal. Since the law tasks the FDA with the job of regulating tobacco products, an amendment to the law would likely be necessary before that responsibility could legally be transferred to another government agency.

0

President Donald Trump has called on pharmaceutical companies to lower huge drug prices.

During a White House meeting with senior pharmaceutical executives President Trump told the companies to manufacture more of their drugs in the US.

However, the president also vowed to help the companies by speeding the approval of new medicines and by cutting taxes.

Donald Trump’s pledges helped to send shares in many of the biggest US drugmakers higher on January 31.

Pharmaceutical companies have faced intense criticism from US politicians – including Donald Trump – as well as insurance companies and patients’ groups over the high cost of new medicines and price hikes in some older generic drugs.

Image source Flickr

Among those attending the meeting were executives from Merck, Johnson & Johnson, Novartis, Amgen and the head of the Pharmaceutical Research and Manufacturers of America (PhRMA) lobbying group.

Donald Trump told them in the meeting: “US drug companies have produced extraordinary results for our country but the pricing has been astronomical for our country, we have to do better.

“We have to get even better innovation, and I want you to move your companies back to the United States.”

To help the drugmakers, Donald Trump said his administration was “going to be lowering taxes big league”.

“We’re going to be getting rid of regulations that are unnecessary – big league,” he added.

Donald Trump’s promise to speed up approvals by the FDA for new medicines sparked strong gains in pharmaceutical shares.

Shares in Merck and Amgen rose by about 1% while Novartis was up more than 2% on Wall Street.

The NASDAQ Biotech Index gained nearly 3% after the meeting and the S&P 500 health care index rose 1.4%.

Investors had sold off shares in drugmakers in recent weeks following heavy criticism from Donald Trump – supported by Democratic Senator Bernie Sanders – over drug pricing.

However, senior pharmaceutical executives welcomed Donald Trump’s proposals on January 31 to cut taxes and loosen regulations.

0

The FDA has approved flibanserin, a desire-enhancing drug for women that has been dubbed “Female Viagra”.

The Sprout Pharmaceuticals drug recently passed an FDA advisory committee meeting.

The non-hormonal pill is designed to assist premenopausal women regain their desire by boosting levels of certain brain chemicals.

However, flibanserin has been criticized as having marginal effects.

Versions of the pill, which will be marketed as “Addyi”, have been submitted for approval in the past but never passed.

The drug was rejected by the FDA twice for lack of effectiveness with results experts admitted were “modest” and side effects like nausea, dizziness and fainting.

Photo AP

Photo AP

Originally the drug was produced by German company Boehringer Ingelheim. Sprout bought the drug from that company after it was turned down by the FDA.

Documents from the June 4 FDA advisory meeting describe the drug’s purpose as “treatment of hypoactive s**ual desire disorder (HSDD) in premenopausal women”.

Women would take it each night.

A doctor would have to determine whether a woman seeking the pill was suffering from a disorder characterized by a lack of desire, causing the woman distress.

Currently, there is nothing on the US market approved for treatment of HSDD or another condition, female s**ual interest/arousal disorder (FSIAD).

“This condition is clearly an area of unmet medical need,” the FDA documents said.

Sprout only has 25 employees. Large pharmaceutical companies like Pfizer, Bayer and Proctor & Gamble have all studied female desire disorder treatment but abandoned plans to pursue it.

Sprout’s CEO, Cindy Whitehead, told AP they would promote Addyi carefully.

“We would never want a patient who’s not going to see a benefit to take it and tell everyone it doesn’t work,” she said.

Lobbying by Sprout Pharmaceuticals was backed by the women’s rights group Even the Score, which has accused the FDA of gender bias by approving a number of drugs treating men’s issues without passing an equivalent for women.

0

The FDA has condemned Kim Kardashian’s promotion of morning sickness prescription drug Diclegis on social media.

Kim Kardashian, who is 5-month pregnant with her second child, posted a selfie last month holding up a branded bottle of the pills alongside text endorsing their effects.

Diclegis maker, Canada-based Duchesnay, later confirmed it had compensated Kim Kardashian for “sharing her experience”.

However, the FDA has attacked the posts for failing to flag potential side effects.

The agency has ordered the drugmaker to stop promoting its product in this manner.

Kim Kardashian’s posts talked of her own use of the drug Diclegis, before stating: “Most importantly, it’s been studied and there was no increased risk to the baby.”Kim Kardashian endorsing morning sickness drug Diclegis

The 34-year-old reality star provided a link to the pharmaceutical company’s own realted safety warnings, but did describe the potential risks herself.

One side effect of a normal dose of Diclegis is drowsiness. An overdose can cause vertigo, mental confusion and an abnormal heart rate.

“The social media post is misleading because it presents various efficacy claims for Diclegis, but fails to communicate any risk information,” FDA division director Robert Dean wrote in a complaint to Duchesnay.

“Because the violations described above are serious and repeated, we request, further, that your submission includes a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed in this letter to the audiences that received the violative promotional materials.”

Robert Dean added that the correction should be distributed “using the same media” as the original messages, indicating that the warnings should appear on Kim Kardashian’s social media accounts.

Kim Kardashian’s selfie has since been deleted from Instagram and Facebook – although a tweet alluding to the posts remains online.

Duchesnay said that it would issue a formal response ahead of a August 21 deadline.

0

The Food and Drug Administration (FDA) says Kim Kardashian’s social media posts violate federal drug-promotion rules.

Kim Kardashian, who is 5 months pregnant with her second child, recently began promoting a prescription pill to treat morning sickness through her social media accounts. Such endorsement deals are relatively common for celebrities.

In posts to Instagram and Facebook earlier this month Kim Kardashian talks about her struggles with nausea due to pregnancy.

The reality star wrote: “I tried changing things about my lifestyle, like my diet, but nothing helped, so I talked to my doctor.

“He prescribed me #Diclegis, and I felt a lot better and most importantly, it’s been studied and there was no increased risk to the baby.”

Kim Kardashian, 34, has over 42 million followers on Instagram and 25 million on Facebook.

The posts link to a company website that includes the FDA-approved labeling information.

Photo Instagram

Photo Instagram

However, FDA regulators say the posts violate rules for promoting drugs because they don’t mention side effects of Diclegis, which include sleepiness that can make it dangerous to drive or perform other activities that require mental alertness. The drug label warns that Diclegis should not be combined with alcohol or other medications that cause drowsiness, such as sleeping aids or certain pain relievers.

FDA regulations require manufacturers to balance benefit claims with information about drugs’ risks, even when space is limited.

The posts also fail to mention that Diclegis is not approved for women with a form of prolonged vomiting that causes dehydration, the FDA notes.

The FDA posted its warning letter online on August 11, addressed to the CEO of Canadian drugmaker Duchesnay Inc., which markets the drug. The letter notes that the privately held company received a similar warning in 2013 for omitting risk information from a letter to doctors.

FDA regulators are “concerned that Duchesnay is continuing to promote Diclegis in a violative manner,” states the letter dated August 7.

The agency calls on the company to remove the social media posts immediately and outline a plan for preventing future violations by August 21

The Quebec-based company said in a statement it “will take quick action in responding to the FDA’s letter and immediately and effectively address any issues”.

The FDA approved Diclegis in 2013 to treat vomiting and nausea in pregnant women who do not respond to more traditional measures. It is the only prescription drug approved in the US for morning sickness.

A different version of the drug was recalled by the agency in 1983 following a series of lawsuits alleging links to birth defects. However, FDA investigations never established any link between the drug and the reported problems.

Kim Kardashian’s posts cited by the FDA no longer appeared on her accounts on August 11.

0

The Food and Drug Administration has approved Spritam, the world’s first 3D-printed prescription drug.

The agency has previously approved medical devices – including prosthetics – that have been 3D printed.

Spritam was developed by Aprecia Pharmaceuticals to control seizures brought on by epilepsy.

Aprecia said that it planned to develop other medications using its 3D platform.

Printing the drugs allows layers of medication to be packaged more tightly in precise dosages.

A separate technology developed by the pharmaceutical company, known as ZipDose, makes high-dose medications easier to swallow.

Printing the drug meant it could package up to 1,000 milligrams into individual tablets.

The 3D-printed pill dissolves in the same manner as other oral medicines.

Photo Aprecia Pharmaceuticals

Photo Aprecia Pharmaceuticals

Being able to 3D print a tablet offers the potential to create bespoke drugs based on the specific needs of patients, rather than having a one product fits all approach, according to experts.

Medical institutions could adjust the dose for individual patients with just a simple tweak to the software before printing. Previously, such personalized medicine would have been extremely expensive to produce.

3D printing works by creating an object layer by layer. In the case of medicines, printers are adapted to produce pharmaceutical compounds rather than polymers which are more usually used.

Such methods are already proving very useful in healthcare with doctors using the system to create customized implants for patients with injuries or other conditions.

Dentists use 3D printers to create replica jaws and teeth as well as other dental implants.

Spritam will launch in Q1 2016, according to Aprecia.

0

A federal advisory panel has urged the Food and Drug Administration (FDA) to approve Sprout Pharmaceuticals’ flibanserin, nicknamed the “female Viagra”.

The experts backed flibanserin, but said it must carry warnings about strong possible side effects including fainting and tiredness.

By a vote of 18-6, the advisory committee to the FDA favored approval of the drug for women whose lack of s**ual desire was not attributable to other causes such as disease or relationship troubles, providing that certain steps were taken to limit the risks of the drug. Doctors might be required, for instance, to inform patients of potential side effects — like low blood pressure, fainting, nausea and dizziness — and physicians might have to become certified to prescribe the drug.

The final decision now moves to the FDA.

Now the drug could be approved by August 18, the FDA’s deadline for making a decision.Flibanserin female Viagra

The FDA has rejected the drug twice since 2010 but it usually follows the advice of its experts.

The agency has previously approved Viagra for men in 1999.

The move was immediately hailed by some women’s organizations. Their controversial campaign by to win federal approval was waged under the banner Even the Score, which accused the FDA of gender bias because it had approved Viagra and other drugs to help men while leaving women without options. The participants in the campaign had been brought together by a consultant to Sprout Pharmaceuticals, the developer of flibanserin.

According to experts, the drug has “modest results”, however, Dr. Julia Heiman of the Kinsey Institute at Indiana University said: “But on the other hand, even modest results can make a lot of difference when you’re at a certain point in the clinical problem.”

One patient who received the drug explained its appeal.

“For us, flibanserin is a relationship-saving and life-changing drug,” said Amanda Parrish.

Some criticized the campaign as providing cover for a drug with marginal effects.

“To approve this drug will set the worst kind of precedent – that companies that spend enough money can force the FDA to approve useless or dangerous drugs,” said, Dr. Adriane Fugh-Berman of Georgetown University, the New York Times reported.

If approved, flibanserin will be aimed at pre-menopausal women.

Thirty thousands of cases of hummus produced by Sabra Dipping Co have been recalled due to possible contamination with listeria.

The FDA announced the recall after inspectors discovered listeria during random testing at a Michigan retail store.

Listeria is a food-borne organism which can cause fever and nausea in most cases, and people make full recoveries.

The disease, listeriosis, can be fatal to people with weakened immune systems, and lead to miscarriages among pregnant women.Sabra hummus recall listeria

The national recall applied to Sabra Classic Hummus brand of the blended chickpea snack – five of its 60 products – although no illnesses have so far been reported.

The contamination was discovered on March 30 at a Kroger grocery store in Port Huron, Michigan.

This is the second food recall related to listeria in the US this week.

On April 9, Blue Bell Creameries expanded an earlier recall after an additional three people in Texas were made ill by its products, according to the CDC.

Three people in Kansas have already died from listeria outbreak.

Food and Drug Administration has rescinded approval of Genentech’ breast cancer drug, Avastin, saying it is not effective enough to justify the risks of taking it.

FDA Commissioner Margaret A. Hamburg, M.D., said today she is revoking the agency’s approval of the breast cancer indication for Avastin (bevacizumab) after concluding that the drug has not been shown to be safe and effective for that use.

Avastin will still remain on the market as an approved treatment for certain types of colon, lung, kidney and brain cancer (glioblastoma multiforme).

“This was a difficult decision. FDA recognizes how hard it is for patients and their families to cope with metastatic breast cancer and how great a need there is for more effective treatments. But patients must have confidence that the drugs they take are both safe and effective for their intended use,” Dr. Margaret A. Hamburg said.

“After reviewing the available studies it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit, in terms of delay in tumor growth, that would justify those risks. Nor is there evidence that use of Avastin will either help them live longer or improve their quality of life.”

Food and Drug Administration has rescinded approval of Genentech' breast cancer drug, Avastin, saying it is not effective enough to justify the risks of taking it

Food and Drug Administration has rescinded approval of Genentech' breast cancer drug, Avastin, saying it is not effective enough to justify the risks of taking it

Avastin’s risks include severe high blood pressure; bleeding and hemorrhaging; heart attack or heart failure; and the development of perforations in different parts of the body such as the nose, stomach, and intestines.

FDA’s decision, outlined in Dr Margaret A. Hamburg’s 69-page opinion, involves Avastin used in combination with the cancer drug paclitaxel for those patients who have not been treated with chemotherapy for their form of metastatic breast cancer known as HER2 negative. This indication must now be removed from Avastin’s product labeling.

Dr. Margaret A. Hamburg’s decision is based on an extensive record, which includes thousands of pages submitted to a public docket, data from several clinical trials and the record from a two-day hearing held in June, 2011.

Avastin was approved for metastatic breast cancer in February 2008 under the FDA’s accelerated approval program, which allows a drug to be approved based on data that are not sufficiently complete to permit full approval.

The accelerated approval program provides earlier patient access to promising new drugs to treat serious or life-threatening conditions while confirmatory clinical trials are conducted. If the clinical trials do not justify the continued approval of the drug or a specific drug indication, the agency may revoke its approval. In this case, the accelerated approval was based on promising results from one study that suggested that the drug could provide a meaningful increase in the amount of time from when treatment is started until the tumor grows or the death of the patient.

After the accelerated approval of Avastin for breast cancer, the drug’s sponsor, Genentech, completed two additional clinical trials and submitted the data from those studies to the FDA. These data showed only a small effect on tumor growth without evidence that patients lived any longer or had a better quality of life compared to taking standard chemotherapy alone – not enough to outweigh the risk of taking the drug.

FDA’s Center for Drug Evaluation and Research, which is responsible for the approval of this drug, ultimately concluded that the results of these additional studies did not justify continued approval and notified Genentech it was proposing to withdraw approval of the indication.

Genentech did not agree with the Center’s evaluation of the data and, following the procedures set out in FDA regulations, requested a hearing on the Center’s withdrawal proposal, with a decision to be made by the Commissioner. That two-day hearing, which took place June 28-29, 2011, included recommendations from the FDA’s Oncologic Drugs Advisory Committee (ODAC), voting 6-0 in favor of withdrawing approval of Avastin’s breast cancer indication. After the hearing, the public docket remained open until Aug. 4, 2011. (In an earlier meeting of the ODAC, that committee had voted 12-1 in favor of the removal of the breast cancer indication from the Avastin label).

“FDA is committed to working with sponsors to bring promising cancer drugs to market as quickly as possible using tools like accelerated approval,” Dr. Margaret A. Hamburg said.

“I encourage Genentech to consider additional studies to identify if there are select subgroups of women suffering from breast cancer who might benefit from this drug.”

 

Listeriosis Outbreak: Jensen Farms Recalls Cantaloupe Due to Possible Health Risk.

 

The FDA announced a recall today for cantaloupes from Jensen Farms, after the Colorado company confirmed that one of its Rocky Ford melons had tested positive for the bacterium Listeria.

A Jensen Farms spokeswoman said today that more tests would be needed to determine whether the strain found in its produce was linked to two confirmed deaths and 16 cases of listeriosis, a potentially deadly infection, The Associated Press reported.

FDA recalls Jansen Farms cantaloupe

FDA recalls Jansen Farms cantaloupe

Amy Philpott, Jensen Farms representative said the farm had shipped more than 300,000 cases across the U.S. between July 29 and September 10 and has recalled the entire harvest.

The U.S. Centers for Disease Control and Prevention (CDC) said that it was the first Listeria outbreak tied to cantaloupe in the U.S.

The listeriosis cases have been reported in five states and Colorado authorities have told retailers to remove Jensen Farms’ cantaloupes from the shelves.

It was also reported that a couple from Denver was expected to file the first lawsuit related to the listeriosis outbreak after the husband ate a Jensen cantaloupe and got sick. The man tested positive for listeriosis and remains hospitalized.

“Jensen Farms continues to stay committed to the highest levels of food safety and maintains many third party safety audits, as we have for many years. We continually look for ways to enhance our protocol,” said Ryan Jensen, partner at Jensen Farms.