Deleted Tweets From Scott Gottlieb, R-D.C.

FDA’s foreign inspections are conducted by either #FDA investigators in one of the foreign offices that we have established since 2008 – in China, India, Latin America & Europe – or by FDA investigators who travel internationally to conduct the inspection.

When we uncover violations, we take appropriate action, regardless of the country in which the manufacturer is located. Action might include regulatory meetings with company leadership, warning letters, seizures, import alerts, or injunction.

Consider the scope of our work in India, the second largest supplier of pharmaceuticals and biologics to the United States. https://t.co/Lwa6Ks6mpL Of FDA’s 1,453 GMP inspections in FY2017, 267 of these inspections were in India.

Although our applications review and inspection programs are robust, they're not the only ways we ensure high-quality drugs. #FDA issues guidance documents for industry on quality issues – 14 in 2017 alone - and meets with sponsors to address questions https://t.co/5vbYsxcxkL.

As part of our life-cycle approach to quality, #FDA keeps track of any changes to approved applications - including process and facility changes - to assess whether the manufacturing process will continue to result in a quality product.

#FDA has made significant progress in our oversight of drugs manufactured overseas. The quality issues we sometimes see in India are similar to what we see elsewhere. We work with manufacturers to ensure they are aware of our standards and expectations. https://t.co/xhuStx6Gsk

Whether U.S-based or foreign, we have committed to inspecting all sites in our inventory by FY 2019, regardless of risk-level. We are currently well ahead of schedule in fulfilling that commitment.

Potential product quality concerns identified by outside sources are also monitored. These include Field Alert Reports https://t.co/6dYzTOm4XR submitted by industry, as well as other reports from healthcare providers and consumers. https://t.co/dVgK9ivfKu

To strengthen our quality efforts, we engage with global regulatory counterparts, exchanging sci and tech expertise & harmonizing inspections & scientific standards approaches with groups like the Pharmaceutical Inspection Cooperation/Scheme (PIC/S) & ICH. https://t.co/fJrUgBXCS4 https://t.co/EttlMdbLTT

Having the same quality standards across markets in multiple countries/regions makes it easier for manufacturers to ensure compliance with quality standards.

To leverage resources, the #FDA updated the Pharmaceutical Annex to the Mutual Recognition Agreement (MRA) between the U.S. and the EU. It facilitates drug GMP inspection report exchanges w/ FDA and recognized member state authorities & reliance on factual findings in the reports https://t.co/kJAAcujvYw

All of these endeavors are examples of the robust framework we've put in place to protect and promote the health of U.S. patients by ensuring that medicines are manufactured to meet quality standards so that they are safe, effective, and free of harmful defects and contamination. https://t.co/Giu1DiKQw4

If necessary, the #FDA or the EU can require further inspections or take other action to protect the public. But the MRA creates greater efficiencies, reduces duplication and allows resources to be reallocated to facilities that pose higher risks. https://t.co/HE0eLjWoPI.

RT @FDAOncology: Dramatically increased survival rates for hematological malignancies and resulting changes in treatment should spur… https://t.co/9uDmYI10Mj

RT @SGottliebFDA: Patients expect and deserve high-quality drugs. In today’s #FDA #SUNDAYTWEETORIAL I’m going to talk about how FDA s… https://t.co/6fJaXOJtSi

RT @US_FDA: Have a problem or adverse reaction to a food, cosmetic or dietary supplement? Contact an FDA Consumer Complaint Coo… https://t.co/CHM6gfnqMC

We need to rapidly increase vaccination coverage to stop spread of #measles in the Americas: https://t.co/5kl6fdQLS9 #GetVax #VaccinesWork #HealthForAll https://t.co/XwGKQghMVh

RT @pkluetz: Registration open for 2nd annual @FDAoncology cancer patient and advocate workshop Nov 27, 2018 on FDA Campus!… https://t.co/RIJiX2tXfs

RT @FDASpox: #FDA took another important step in our efforts to protect patients. We issued an FRN regarding 3 bulk drug substan… https://t.co/pYDRzcObXh

#FDA is taking new steps to continue implementation of DQSA and our policies supporting pharmacy compounding and outsourcing facilities; with the goal of advancing the industry while ensuring the safety and quality of compounded products. https://t.co/0lguLYMLXO

FDA’s foreign inspections are conducted by either #FDA investigators in one of the foreign offices that we have established since 2008 – in China, India, Latin America & Europe – or by FDA investigators who travel internationally to conduct the inspection.

When we uncover violations, we take appropriate action, regardless of the country in which the manufacturer is located. Action might include regulatory meetings with company leadership, warning letters, seizures, import alerts, or injunction.

Consider the scope of our work in India, the second largest supplier of pharmaceuticals and biologics to the United States. https://t.co/Lwa6Ks6mpL Of FDA’s 1,453 GMP inspections in FY2017, 267 of these inspections were in India.

Although our applications review and inspection programs are robust, they're not the only ways we ensure high-quality drugs. #FDA issues guidance documents for industry on quality issues – 14 in 2017 alone - and meets with sponsors to address questions https://t.co/5vbYsxcxkL.

As part of our life-cycle approach to quality, #FDA keeps track of any changes to approved applications - including process and facility changes - to assess whether the manufacturing process will continue to result in a quality product.

#FDA has made significant progress in our oversight of drugs manufactured overseas. The quality issues we sometimes see in India are similar to what we see elsewhere. We work with manufacturers to ensure they are aware of our standards and expectations. https://t.co/xhuStx6Gsk

Whether U.S-based or foreign, we have committed to inspecting all sites in our inventory by FY 2019, regardless of risk-level. We are currently well ahead of schedule in fulfilling that commitment.

Potential product quality concerns identified by outside sources are also monitored. These include Field Alert Reports https://t.co/6dYzTOm4XR submitted by industry, as well as other reports from healthcare providers and consumers. https://t.co/dVgK9ivfKu

To strengthen our quality efforts, we engage with global regulatory counterparts, exchanging sci and tech expertise & harmonizing inspections & scientific standards approaches with groups like the Pharmaceutical Inspection Cooperation/Scheme (PIC/S) & ICH. https://t.co/fJrUgBXCS4 https://t.co/EttlMdbLTT

Having the same quality standards across markets in multiple countries/regions makes it easier for manufacturers to ensure compliance with quality standards.

To leverage resources, the #FDA updated the Pharmaceutical Annex to the Mutual Recognition Agreement (MRA) between the U.S. and the EU. It facilitates drug GMP inspection report exchanges w/ FDA and recognized member state authorities & reliance on factual findings in the reports https://t.co/kJAAcujvYw

All of these endeavors are examples of the robust framework we've put in place to protect and promote the health of U.S. patients by ensuring that medicines are manufactured to meet quality standards so that they are safe, effective, and free of harmful defects and contamination. https://t.co/Giu1DiKQw4

If necessary, the #FDA or the EU can require further inspections or take other action to protect the public. But the MRA creates greater efficiencies, reduces duplication and allows resources to be reallocated to facilities that pose higher risks. https://t.co/HE0eLjWoPI.

RT @FDAOncology: Dramatically increased survival rates for hematological malignancies and resulting changes in treatment should spur… https://t.co/9uDmYI10Mj

RT @SGottliebFDA: Patients expect and deserve high-quality drugs. In today’s #FDA #SUNDAYTWEETORIAL I’m going to talk about how FDA s… https://t.co/6fJaXOJtSi

RT @US_FDA: Have a problem or adverse reaction to a food, cosmetic or dietary supplement? Contact an FDA Consumer Complaint Coo… https://t.co/CHM6gfnqMC

We need to rapidly increase vaccination coverage to stop spread of #measles in the Americas: https://t.co/5kl6fdQLS9 #GetVax #VaccinesWork #HealthForAll https://t.co/XwGKQghMVh

RT @pkluetz: Registration open for 2nd annual @FDAoncology cancer patient and advocate workshop Nov 27, 2018 on FDA Campus!… https://t.co/RIJiX2tXfs

RT @FDASpox: #FDA took another important step in our efforts to protect patients. We issued an FRN regarding 3 bulk drug substan… https://t.co/pYDRzcObXh

#FDA is taking new steps to continue implementation of DQSA and our policies supporting pharmacy compounding and outsourcing facilities; with the goal of advancing the industry while ensuring the safety and quality of compounded products. https://t.co/0lguLYMLXO