In a very grim view of this, there are lives that are going to be lost because patients won't get access to these drugs.

Scott Gottlieb

Categorized in : Health News

Access to affordable insulin can be a matter of life and death for Americans with diabetes. Insulin is a critical hormone that regulates sugar metabolism, but access to this critical drug can be increasingly difficult for these Americans. Insulin list prices regularly increase by double digits annually.

Mammography is the best tool in determining if a woman has breast... by Scott Gottlieb

Mammography is the best tool in determining if a woman has breast cancer.

We won't ignore data regarding the popularity of mint - and menthol-flavored [ vapes ] among kids, should the concern rise, we'll continue to use all available resources to monitor the rates and use patterns among youth and adults for these products, and we'll reconsider our policies with respect to these products, if appropriate.

The FDA did this in a fashion that's going to allow us to put in place additional restrictions if the youth rates continue to grow, it allows us to very quickly adjust our policy further.

When a consumer goes online to buy medicines purportedly from Canada, they may get a medicine sourced from elsewhere that could be counterfeit, expired or misbranded. While operations or illegal online pharmacies may state on their websites that its medicines are coming from Canada, the United Kingdom, Australia, etc., this is not necessarily always the case, such operations and illegal online pharmacies take advantage of unsuspecting Americans by purporting to distribute safe and effective imported drugs, at least some of which are instead expired, mislabeled, subject to recalls or potentially counterfeit and that are provided outside of the closed American distribution system meant to protect patient safety.

It's important to underscore that, based on the FDA's initial evaluation, the increased risk of cancer to patients with NMBA exposure appears to be the same for NDMA exposure but less than the risk from NDEA exposure. That said, any presence of such impurities in drug products is not acceptable. Over the past few months, the FDA has conducted a major investigation and has worked with drug companies to address the presence of impurities in these products, our ongoing effort has determined that the impurities may be generated by specific chemical reactions in the manufacturing process of the drug's active pharmaceutical ingredients. FDA scientists have developed novel and sophisticated testing methods specifically designed to detect and measure N-Nitrosodimethylamine( NDMA) and N-Nitrosodiethylamine( NDEA) impurities in ARB medicines. Because of the potential for discovering other nitrosamine impurities, we are conducting an extensive organic chemistry analysis to develop novel testing methods to detect additional nitrosamine impurities, including NMBA.

As part of our Youth Tobacco Prevention Plan, we'll continue to employ all the tools at our disposal to monitor, penalize and prevent sales of all tobacco products, including e-cigarettes, to minors at brick-and-mortar stores and Internet storefronts as we work to ensure these products are sold in ways that make them less accessible and appealing to kids.

Our generics and biosimilars programs will however be impacted should the lapse in funding continue, we continue to operate the programs using carryover user fees, and we'll prioritize work that impacts public safety, as this is our foremost priority.

We're shifting operating dollars to payroll dollars in order to maximize our runway and preserve program functions.

The FDA re-starting high risk food inspections as early as tomorrow. The FDA'll also do compounding inspections this week. And The FDA started sampling high risk imported produce in the northeast region today. The FDA'll expand The FDA footprint as the week progresses. The FDA teams are working.

Wherever we can, we will look at the safety mission first and foremost, but you know what will happen is that more of the routine work and more of the day-to-day review work will slow down, a lot of it slowed down already.

The most challenging part of this is the human capital side of this, we are asking a lot of people to do work that will miss a paycheck, and not everyone is at the high end of the pay scale. I used to live paycheck to paycheck. We know people will be in difficult circumstances, and we are asking them to do hard things.

I'm so proud to lead an agency driven by so many dedicated people. Working on a holiday, and through a government shutdown, to fulfill their commitment to America.

It's my belief that we've been successful in this country at stigmatizing tobacco products among kids, we haven't been effective stigmatizing e-cigarette use.

We see clear signs that youth use of electronic cigarettes has re... by Scott Gottlieb

We see clear signs that youth use of electronic cigarettes has reached an epidemic proportion.

We cannot allow a whole new generation to become addicted to nico... by Scott Gottlieb

We cannot allow a whole new generation to become addicted to nicotine.

While we remain committed to advancing policies that promote the potential of e-cigarettes to help adult smokers move away from combustible cigarettes, that work can’t come at the expense of kids.

We do think the e-cigarettes could offer a potential opportunity for adult smokers to transition off of combustible tobacco on to reduced risk products.

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I’m very concerned about youth becoming addicted to nicotine through things like e-cigarettes … what we don’t want to see is a whole generation of children become addicted to nicotine from the use of e-cigarettes.

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Widespread reports of youth use of JUUL products are of great public health concern, youth may not understand the nicotine or other characteristics of Juul Labs.