When a doctor gives you a shot of an experimental hepatitis C treatment, you may not remember that the doctor was a drug company lobbyist who is still fighting to make sure you get the drug.
That’s because the company’s new drug, SMAQ-A2, is being marketed as a treatment for hepatitis A. The drug has been approved by the Food and Drug Administration (FDA) to treat a type of liver disease called cirrhosis of the liver.
It’s one of many hepatitis drugs that has come onto the market with little or no public information about the risks and side effects.
“We have an obligation to tell the public the most relevant information and that we are using all available scientific evidence in making our clinical decision, which is to recommend the use of this treatment,” said Dr. Robert O’Brien, chairman of the FDA’s drug safety panel.
“It is important that patients understand what they are receiving, what they should be receiving and what they shouldn’t be receiving, because those are the most important information,” he added.
The FDA’s panel is reviewing the drug’s safety and efficacy data, and will issue its final decision in late September.
As a result of that review, SMIQ-a2 will not be approved for people younger than 65.
“SMIQA2 is a perfect storm of circumstances that make the potential for a catastrophic outcome not only unlikely, but very real,” said Sen. Tom Carper, a Maryland Democrat who represents the Baltimore suburb of Annapolis, which has one of the country’s highest rates of hepatitis A cases.
He is a member of the Senate’s Committee on Finance and is urging the FDA to reject SMAq-a1, which was approved in 2015.
The new drug has a shorter half-life of about three months, compared to more than a year with SMAaq-a4, which also has a lower half-lives.
The U.S. hepatitis A drug market is expected to be worth $5.5 billion this year.
SMAqs-a3, a new drug in the same class as SMAqt-a, is the first hepatitis A treatment approved by a major U.K. drugmaker.
Its approval came after a six-month clinical trial showed that the drug could be effective against cirrhotic patients, as well as for people who are sick with the liver disease.
In the first year of clinical trials, the SMAqa-a drug was shown to be more effective than SMAqua-a and SMAb1, two drugs currently on the market.
SMIq-A and SMIqa-A are two of the first drugs approved by U.N. experts for hepatitis B and C. But those two drugs have also been associated with serious side effects, including liver failure, kidney damage and even death.
In a statement, the FDA said the safety and effectiveness of SMAqi-a is still under review.
The company said it is “reviewing the safety of the SMIqs-A3 drug in conjunction with the FDA and will provide updates as warranted.”
SMIqua has been on the FDA drug approval list since 2009.
But Carper has called on the agency to reject the drug that was approved with the most favorable safety data possible, arguing that it has been a “disgraceful example of how the FDA has been slow to act to prevent the killing of Americans in the name of safety.”
“The FDA should not be in the business of approving risky treatments that kill American lives,” Carper said in a statement.
“When the agency’s own scientists have shown the drugs are unsafe and dangerous, it is time to reverse that decision.”
The FDA will not approve SMAque-a as a therapeutic for hepatitis because it’s not approved for use in people older than 65 and because SMAqua is a brand name, not a brand drug, according to the FDA.
It will be up to the manufacturer to provide the data required by the FDA before it can approve SMIqt-A or SMIqi-A for use as a hepatitis treatment, according a statement from the FDA on Monday.
The SMA Quays, a small Baltimore neighborhood in Annapolis that has a higher hepatitis A rate than any other part of the city, is home to many people with cirrhotics, said Dr ina Vazquez, an Annapolis resident who has been taking SMIque-A since 2014.
“The drug’s been out there for six years, and it’s a real concern,” she said.
“I would like to see them take a look at SMIQUA as well.”
The drug company has filed an emergency petition with the federal court system in Maryland challenging the FDA approval.
The filing asks that the court deny the FDA ruling, noting that the agency has already approved SMA qqA and the Sma qq A3 drug,