The Federal Drug Administration is notoriously slow in approving new drugs of all types for a variety of reasons. The primary reason is the agency wants to ensure the product actually does what the manufacturers claim it can do, as the agency is generally concerned about approving effective medications. Public safety is also a serious concern, as there can be many negative side effects and even serious consequences when drugs are approved on a fast track process. It commonly takes an average of twelve years of testing and approximately $350 million to get a new drug through the red tape of the Federal Drug Administration, which is a significant deterrent for many new medications within itself.
Apply for a Patent
The first step in getting a male fertility drug approved is applying for the legal rights to the formula compound. This is important even for drugs that may or may not be approved. Sometimes testing can take longer than expected when results are not consistent with manufacturer claims, but it is still important to hold the intellectual rights for the process because future adjustments to the compound could produce the indicated effectiveness. It’s important for pharmaceutical drug companies to comply with regulations, or else their medications can’t be sold. Plus, they make a lot of money on fertility drugs because most insurance policies don’t cover fertility drugs. That’s what makes them different from other medications.
PDMA Compliance
All male fertility drugs are required to meet the specifications of the Prescription Drug Marketing Act that controls actions by all parties involved in submitting and marketing a specific drug. It is especially targeted at third-party suppliers that may produce counterfeit versions of an approved medication. Each individual state also implements PDMA compliance regulations for all pharmaceutical manufacturers within the state with respect to the actual dispensation of any particular drug. This layered scrutiny is intended to ensure drug use safety for all patients while also determining a proper consistency in dosages.
FDA Approval Process
The actual approval process in generally conducted in five stages. After initial approval application by the pharmaceutical company, the drug will then be tested in a variety of methods including clinical research and experiments. This begins in the third stage of the process. Drugs that clear this testing level will be used in clinical trials with animals as the first testing subjects in the fourth stage. The final stage of testing is a controlled clinical trial for a selected group of humans who will take valid active ingredient compounds compared to an additional human testing group that will be administered a placebo. Those drugs passing the human testing phase will usually be approved.
The obvious difficulties in approving a new drug have been a natural obstacle for the approval of new male fertility drugs. This is exampled by the relatively few options men have when seeking medical help for an impotency problem. But, technology is improving steadily and new options may be available in the future.
