Dr. Stephen M. Hahn Profile picture
Sep 9, 2018 23 tweets 8 min read Twitter logo Read on Twitter
Compounded drugs serve an important medical need for patients who can’t use an FDA-approved medication. In today’s #FDA #SUNDAYTWEETORIAL, I’m going to talk about what FDA is doing to preserve access to appropriately compounded drugs while protecting patients from serious risks.
In drug compounding, ingredients are combined, mixed or altered to create a sterile or non-sterile medication tailored to a patient - such as those with an allergy who need a drug without a certain dye or a child who can’t swallow a tablet and needs medicine in a liquid form.
But compounded drugs, which aren’t FDA-approved, may pose serious risks if not produced properly, potentially resulting in contamination or medications that do not possess the strength, quality or purity they are supposed to have bit.ly/2G7IpjB
In 2012, contaminated compounded steroid drugs were injected into patients in multiple states. Hundreds of people developed fungal meningitis and other infections, and scores died.
The outbreak illuminated the need for improved compounding practices, more robust oversight, close federal/state collaboration, and a clear legal framework with tools for FDA to address unlawful compounding practices.
Also apparent was the need to better define and regulate compounding facilities acting as large-scale drug manufacturers, outside FDA’s routine oversight. Congress responded with the Drug Quality & Security Act (DQSA). bit.ly/2QaoRR0
The DQSA enabled FDA to fully implement & enforce existing law about traditional compounders – licensed physicians/licensed pharmacists in state-licensed/federal facilities - and created a new compounding category, outsourcing facilities. bit.ly/2xoV01R
Pharmacy compounders produce medicines for an individual patient with a valid prescription and states continue to have day-to-day oversight.
Outsourcing facilities may engage in larger-scale, nationwide distribution with the potential to expose more patients to risks. They must meet FDA’s CGMP requirements, be inspected by FDA according to a risk-based schedule, report adverse events and meet other conditions.
Since 2013, we have made great strides in DQSA implementation through robust inspection and enforcement, policy development, oversight and stakeholder outreach. We have also convened advisory committee meetings to get scientific advice and collaborated with the states.
FDA continues to learn of cases of patient illnesses & death due to improperly compounded drugs. In 2017, at least 43 patients developed vision loss after injection in the eyeball with a compounded combination of a steroid and and anti-infective drug during cataract surgery.
We pursue a risk-based & for-cause approach to inspections and enforcement, focusing on sterile compounding. Since 2013, there have been 201 for-cause inspections (adverse events, product quality, facility concern), 272 surveillance inspections and 188 follow-up inspections.
Sterile compounding requires a controlled environment with filtered air, controlled pressure, particle monitors, special equipment & protective clothing. We continue to observe sterile compounding outside controlled environments & in egregious conditions w/ mold growth & vermin.
The vast majority of compounding inspections since Oct. 2012 have led to voluntary recalls (220) or regulatory actions (227 warning letters). FDA has also pursued civil injunctions and criminal actions. bit.ly/2NXeyyb
To fully realize the DQSA framework, we have also issued 22 draft and revised draft guidance documents and finalized 15. We have also issued 3 rules – finalizing one – and issued a revised draft Memorandum of Understanding with the states. bit.ly/2juTHnN
Our Drug Compounding Policy Plan for 2018 bit.ly/2IbQZiM lays out how we address quality standards for outsourcing facilities, regulate compounding from bulk drug substances, and restrict compounding of drugs that are essentially copies of FDA-approved drugs.
Two revised draft guidances are coming soon - one relates to insanitary conditions at compounding facilities and a second relates to current good manufacturing practice (CGMP) requirements tailored to the operations of outsourcing facilities.
One 2018 goal is solidifying our partnership with state regulatory authorities who license and set standards for compounding pharmacies and investigate and respond to complaints about them and their compounded drugs. I look forward to our annual 50-state meeting in late Sept.
The revised draft MOU bit.ly/2NYfan8 would have states ID & report info to FDA on compounders that distribute compounded drugs out of state in inordinate amounts > 50% of total prescription orders. This info will assist FDA in developing risk-based oversight priorities.
States also would investigate complaints relating to compounded drugs, including reports of serious adverse events or serious product quality issues and notify FDA.
In earlier draft MOU, states had to act against compounders for shipping >30% of their compounded drugs out of state. But some said this could impede access to needed drugs from pharmacies that specialize in drugs to treat certain conditions and ship nationwide, so FDA revised.
And our revised cGMP guidance will provide a more flexible standard for how we enforce GMP requirements based on risk; to enable smaller compounders who are engaging in activities posing less risk to comply without incurring significant expenses on new equipment, facilities, etc
FDA’s compounding program is a priority. As the revised draft MOU shows, we are balancing the need to preserve access to appropriately compounded drugs for patients who need them with the need to protect patients from poor quality compounded drugs that could cause harm.

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More from @SteveFDA

Sep 30, 2018
It’s the start of flu season – time to protect yourself and your family by getting vaccinated! In today’s #FDA #SUNDAYTWEETORIAL I’m going to talk about #FDA’s role in ensuring the safety, effectiveness, and availability of the 2019 influenza vaccines. #VaccinesWork #FightFlu
I know there are questions about the effectiveness and benefits of the flu vaccine given the severity of last year’s flu season, so I want to update you on what we’ve learned, the effectiveness of this year’s vaccine and why vaccination is important go.usa.gov/xPWhS.
We've made important modifications to this year's #Flu vaccine to improve its effectiveness; changing two of the strains (for the H3N2 and Influenza B components) to better reflect the influenza strains that we believe are most likely to circulate this winter. More on this later.
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Sep 2, 2018
As kids are heading back to school, for this #FDA #SUNDAYTWEETORIAL I’m going to talk about MEASLES and the vital importance of vaccination. You may’ve seen recent news stories reporting cases of measles in parts of the US and EU. Most cases have occurred in unvaccinated people
In 2018 there have been 124 individual cases of measles in 22 states and D.C. Measles can spread when it reaches a community where there are groups of unvaccinated people. And travelers with measles continue to bring the disease into the United States go.usa.gov/xUzwa
Measles is caused by the rubeola virus and is highly contagious. It is normally passed through direct contact or through the air. The virus infects the respiratory tract, then spreads throughout the body, causing a skin rash, fever, cough and runny nose.
Read 19 tweets
Aug 19, 2018
Consumers want and expect safe, wholesome and affordable food. They deserve nothing less. In today’s #FDA #SUNDAYTWEETORIAL I’m talking about what steps the FDA, the states and produce farmers are taking - in collaboration - to ensure the safety of fresh fruits and vegetables.
We hear too often about food safety concerns involving fresh fruit and vegetables -most recently the outbreak of E. coli O157:H7 infections associated with romaine lettuce from the Yuma growing region, the largest such outbreak in the U.S. in more than 10 years.
From 1998-2008 there were 455 produce-associated food outbreaks, with more than 16,000 people becoming ill, more than twice the number of produce-associated illnesses from 1973-1997. This is a significant public health burden that should be largely preventable.
Read 25 tweets
Jul 30, 2018
THREAD ON NEW ENFORCEMENT ACTION: We’re taking action against manufacturers marketing “vaginal rejuvenation” devices to women by deceptively claiming the procedures treat conditions and symptoms related to menopause, urinary incontinence, & sexual function fda.gov/NewsEvents/New…
These products have serious risks and don’t have adequate evidence to support their use for these purposes. We’re deeply concerned women are being harmed by these procedures
In some cases, the devices are marketed to women who’ve completed treatment for breast cancer and experience symptoms caused by early menopause. Deceptive marketing of a dangerous procedure with no proven benefit, including to women who’ve been treated for cancer, is egregious.
Read 7 tweets
Jul 29, 2018
For this weekend's #FDA #SUNDAYTWEETORIAL I’m going to talk about what FDA is doing to modernize clinical trials to reduce the cost of drug development, potentially lower drug costs and bring more safe, effective therapies to patients.
FDA’s mission is to both promote and protect public health. For medical products, this means ensuring that they are safe and effective for their intended use. Clinical trials are the primary vehicle for generating the evidence FDA needs to ensure that.
The traditional drug development paradigm calls for 3 clinical trial phases: A small phase 1 tests safety and dosing, phase 2 tests short-term side effects and effectiveness over a range of doses; and the large phase 3 assesses whether the product’s benefits outweigh its risks.
Read 22 tweets
Jul 15, 2018
The topic of this week’s #FDA #SUNDAYTWEETORIAL is #drugshortages. FDA does everything possible within our authority to help address shortages. While we’ve made progress to mitigate shortages; we must do even more to understand and address the root causes of persistent shortages
Manufacturing & quality issues are some of the proximate causes of drug shortages. Availability of raw materials; unexpected increases in demand, i.e. due to illness outbreaks or changes in clinical practice; or unavailability of other drugs in a class also can lead to a shortage
We’ve seen # of new drug shortages steadily decline due to work by FDA, industry and others. In 2017, we worked w/ manufacturers to prevent 145 shortages. There were still 35 new shortages last year, but this compared to peak of 251 new shortages in ‘11 bit.ly/2JiNGpf
Read 17 tweets

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