Nowhere is this challenge more important than in the emerging area of follow-on biologics (otherwise known as FOBs), a class of drugs made from organic, living material. Follow-on biologics are responsible for some of the most advanced care available to patients suffering from cancer, diabetes and other debilitating diseases.
While the recent debate over how to guide FDA approval of FOBs has largely been settled in Congress, the overall healthcare reform legislation continues to be in a state of flux. To the extent that the FOB approval pathway has not yet been settled and there is speculation about reopening the debate, seemingly all of the attention is focused on the term of exclusivity.
This focus is extremely shortsighted, and ignores the broader need of ensuring patient safety for both current and future drugs.
Follow-on biologics are similar to generic chemical drugs in that they seek to mimic the medical qualities of existing drugs. But unlike simple generic drugs, which are identical to the original, it is not possible to create an identical biologic copy of the original drug because of the living proteins and carbohydrates used to make them. Follow-on biologics can have tremendous therapeutic value and save money for patients, but the complexity of the genetic engineering demanded for producing them creates serious safety concerns.
Because it’s impossible for FOBs to be identical to the innovator drug, strict attention must be paid to proper testing for FOBs. Diligence must also be exercised in how Congress approaches the more than 40 protein and carbohydrate biologics that are already being prescribed to patients. Questions of patient safety that hinge on the interchangeability and immunogenicity of FOBs can be answered only through rigorous and comprehensive human testing.
FOBs should also be subject to post-marketing study and surveillance to ensure that the safety factors established in theory actually exist in practice. Only these actions can ensure that we’re placing a higher premium on patient safety than other considerations.
The term “unintended consequences” has become almost a political cliché, but avoiding such consequences must be the standard for action when it comes to the patient safety and medical efficacy issues surrounding follow-on biologics. Before Congress sends a final healthcare bill to President Barack Obama for his signature, it would be well served to ensure that these safety criteria are included in the legislation. To do otherwise would risk the health and lives of patients.
Obama’s contradiction on foreign policy
From Helen Tackett
President Barack Obama’s Cairo speech in June cited an unfortunate, long history of Western colonialism of Muslim countries and the United States’s habit of treating Muslim countries as Western proxies. Obama promised Americans and the Muslim world that he would not repeat this ugly history.
Today, President ObamaBarack Hussein ObamaEmanuel to take hot seat in Senate confirmation hearing Public officials are under physical and digital siege We must protect and support our health care safety net MORE absurdly expects Americans and Afghanis to accept the rigged election of Hamid Karzai as a legitimate democratic election. U.S. troops’ presence in Afghanistan enforced President Obama’s desire to have Karzai as president of Afghanistan.
President Obama undermines democracy in Afghanistan while justifying our troops’ presence there with the rationale that they are fighting and sometimes dying for that country’s democracy.
Where is the change that Obama promised us?