The Future of Topical Anticoagulants Is Still in Crisis
The future of topical anticoagulation is still in flux, and the battle over whether to give them to patients or not is playing out in the court of public opinion.
It’s unclear whether the drugmakers are even thinking of giving the drugs to patients in the first place.
And with a number of other pharmaceutical companies already making the drugs, and several others planning to, the question of who should pay for them will become more complicated.
“They’re already getting the drugs.
They’re just not getting any money from the patients,” says Daniel Dovidio, president of the American College of Chest Physicians, who is helping advocate for a drugmaker to be allowed to pay for a small portion of the drug.
Dovicos group wants a prescription-only drug that would allow patients to get their prescription drugs without having to buy anything else, while a smaller drug would allow them to buy the drug directly from a pharmacy, and get it shipped directly to their door.
“I think that is the right approach, given the need for these drugs,” says Dovio, who also serves on the FDA’s board of directors.
“We need to have the ability to prescribe them to the patients who need them, who have been shown to be at higher risk of serious adverse reactions, and who need these drugs to treat some of the more severe cases of these conditions.”
The FDA’s position is a bit different, though.
The agency has said that it is committed to protecting the safety of patients and that it wants to encourage the use of the drugs when they are prescribed.
But it has also said that there are many reasons why the drugs could not be given to everyone.
A 2014 study published in the Journal of the European Medical Association found that more than 10 million people in the United States could not get a prescription for a particular drug, including the ones given to people with HIV or AIDS, or those with pre-existing conditions.
A 2015 study published by the American Journal of Public Health found that people who took topical anticholinergic drugs had a greater risk of developing a new type of heart disease.
That study, though, wasn’t about who should be allowed the drugs; it was about what should happen if the drugs were given to millions of people.
The FDA said it is reviewing the data, and Dovi’s group has asked the agency to look into whether the agency should allow prescription-based drug pricing.
A spokeswoman for the agency told Wired in a statement that the agency will not be taking a position on any proposals before they are submitted to Congress.
But the agency could change its mind if the drugmaker makes more than $1 billion in sales per year from the sale of the medications.
The company that makes the drugs says that the drugs are safer than other drugs and are a boon to people in dire need of a heart-attack treatment.
“Our primary focus is on patient safety and minimizing adverse events, not profit,” Dr. William C. P. Reisman, the company’s vice president of research and development, told Bloomberg Businessweek in 2015.
“As for our costs, they are much lower than what we pay to pharmaceutical companies.”
The agency is also looking into the company behind the drugs—Cephalon Pharmaceuticals, which has been developing the drugs since the 1990s.
In a statement to Wired, the FDA said that “the FDA does not have jurisdiction over the companies that develop and sell topical anticancer drugs.”
But the company says that it “has not paid a dime to the FDA since the FDA began requiring drugmakers to pay royalties for all FDA-approved topical drugs in 2009.”
Reisman also said to Bloomberg that he doesn’t think the agency would allow him to discuss the matter in an official capacity, given that he is a senior adviser to the company.
“There is no question that the FDA has a role in determining whether these drugs are safe and effective, and it should not be able to dictate to any of these companies how to manage their business,” Reisman said.