The US Food and Drug Administration (FDA) has proven time and time again that they are incapable of properly regulating the pharmaceutical industry. In the latest Pfizer drug approval, the FDA proved that they work for Pfizer and helped fast track a drug approvals in an anti-competitive way.
FDA regulators recently reached out to Pfizer, urging them to apply for a new drug indication for their blockbuster cancer drug Ibrance. With this move, FDA regulators show that they will go out of their way to track down their friends at Pfizer and give them priority for new label expansions. After Pfizer was given the inside track, they quickly applied for the label expansion, monopolizing on cancer treatment fraud through their connections at the FDA.
The FDA tips off Pfizer for label expansions, drug approvals
This year, Pfizer reported that the FDA expanded a full approval for Ibrance. The new approval is for a combination of Ibrance and an aromatase inhibitor that can now be prescribed to newly-diagnosed HR-positive, HER2-negative metastatic breast cancer patients, regardless of their menopausal status. The combination drug was previously approved only for postmenopausal women.
A careful examination of the prescription information for Ibrance shows no new efficacy data in the patient population. In fact, there is no update on clinical efficacy for Ibrance’s label. The label only includes the original results from the phase 4 PALOMA-2 trial and the phase 3 PALOMA-3 study. The first study only tested a combination of Ibrance and Novartis aromatase inhibitor Femara in postmenopausal women who were newly diagnosed with HR+/HER2- breast cancer. The PALOMA-2 trial failed to produce any convincing data for Ibrance’s efficacy. In fact, Ibrance failed to significantly improve the life expectancy of patients enrolled in the study.
The second study combined Ibrance with AstraZeneca’s SERD drug Faslodex for patients who were previously treated, regardless of menopausal status. Pfizer did not produce any new clinical data, yet the FDA went out of their way to help Pfizer expand their Ibrance label so that it can be prescribed to all women who meet the diagnostic criteria. The FDA’s latest approval letter (dated Dec. 13, 2022) openly admitted that the FDA reached out to Pfizer in December 2021 and requested they file an application to include pre/perimenopausal women in Ibrance’s label. Pfizer submitted the application for expanded market authorization for Ibrance on March 11, 2022, already knowing that the FDA would approve it, because the FDA requested it in the first place.
Pfizer’s regulatory capture of the FDA allows for historic crimes against humanity
Other drug companies are unable to compete with Pfizer because the FDA communicates directly with Pfizer and provides an inside track for their drug approvals. Novartis’s competing drug Kisqali and Eli Lilly’s drug Verzenio were not given the same special treatment for license approval and expansion. The FDA’s favoritism of Pfizer has nothing to do with science or data, and has everything to do with the revolving door they have with the government.
How else would Pfizer continue to get away with their crimes against humanity in regard to the covid-19 vaccine? Pfizer was the first pharmaceutical company to get FDA authorization for the covid mRNA jab because there is a revolving door of fraud between Pfizer and the government. For instance, in June of 2019, Dr. Scott Gottlieb joined Pfizer’s Board of Directors, which was two months after he finished his term as Commissioner of the FDA. One year later, Pfizer received over $2 billion from Operation Warp Speed to expedite mRNA experiments on the population. Now, the FDA is making way for endless approval of Pfizer’s “directed evolution” experiments and yearly covid jab boosters, despite there being no evidence of efficacy or safety for the jabs.
After forcefully and criminally generating $100.3 billion in revenue in 2022 and $81.3 billion in 2021, this criminal organization [Pfizer] continues to grant itself more power over the population and the rule of law through the regulatory façade, the fully-captured FDA.
Sources include:
AccessData.FDA.gov [PDF]
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