More generic drugs will be available in the market, if the Bill introduced by four US Senators will be carried out. Two Republicans and Two Democrat senators institute a bill that aims to prevent big pharmaceutical companies to use safety rules to stop the commercialization of generic drugs in the market. The sponsors of the said Bill were Senator Charles Grassley, Sen. Patrick Leahy, Sen. Amy Klobuchar and Sen. Mike Lee. Senator Grassley is the chair of Judiciary Committee while Senators Lee is the chair of antitrust subcommittee.
The US Food and Drug Administration is the agency assigned to ensure the safety of the food and drug supply of the country. FDA uses REMS or Risk Evaluation and Mitigation Strategy Program to ensure that the riskiest or dangerous drugs are distributed safely.
But there are objections regarding FDA’s REMS. There are complaints that REMS has been misused by big pharmaceutical companies having a branded drugs to prevent generic manufacturers from getting hold of the drug samples which they need to market replica drugs in a cheaper price. Generic manufacturers are also complaining that they are not allowed to present a safety protocol which makes their replica drugs difficult to penetrate the market.
The Bill will give a generic manufacturer the right to file appropriate charges to force a company with branded-drug to provide a sample of the drug. The generic company can also force negotiations so they can have a safety protocol.
Grassley said in a press release statement that he will be consistent in supporting generic drugs. He said that there should be a balance between developing a lifesaving medication and making it affordable to the market. Grassley also said that this is a very difficult task to balance.
He also noted that there are some drug companies with branded-drugs that use anti-competitive tactics to delay the entry of generic drugs in the market. The bill will help ensure consumers that the laws are not used for the benefit of the few.
The House of Representatives has a similar Bill which tackles the same issue but it uses a different tactic. As an example, if a generic company wants to seek a sample of the REMS drug, they should get an FDA authorization first.
One of the popular REMS disputes that gone public was when Mylan Pharmaceuticals filed charges against Celgene Corp. in 2014. Mylan accuses Celgene of using REMS to prevent them to get copies of Revlimid and Thalomid samples.
The hearing for this Bill will be held on June 21 at the antitrust panel of the Senate Judiciary Committee.
The PhRMA or Pharmaceutical Research and Manufacturers of America which is the organization of the major drug makers said that they do not have a comment yet regarding this matter.
While the Generic Pharmaceutical Association was satisfied to know that the Senate is taking action on this issue.
Chip Davis, the President of Generic Pharmaceutical Association said that it is worthy to recognize the efforts of the representatives to emphasize the role of generic drugs in driving the health care savings. He also noted that the anticompetitive practices forced by certain drug manufacturers will do the exact opposite of the outcome.
Branded Versus Generic
Branded drugs are expensive because it took years to research and develop the drug. They also spent millions or billions of dollars for the research, clinical studies, and experimental trials and so on. The pharmaceutical company wants to get a return of investment on the drug and their putting all the costs at the patient’s expense.
On the other hand, generic drugs offer a much lower price because they make replica drugs. They do not spend any money for the research and clinical trial; they will only have to spend in making an exact copy of the drug.
But before a drug can be made available for a generic manufacturer, it has already been in the market for a specified number of years like 10 years. At this time frame, it is presumed that the branded drugs have already earned more than enough revenue for their lead drug.
Thus, this Bill will help not only the generic manufacturers but the patients as well. Grassley is right in saying that there should be a balance in lifesaving medication and affordable medicines.