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FDA Approval of New Drugs One of Many Goals for Drug Manufacturers

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The US pharmaceutical market, together with those of Canada and Mexico, make more than half the global pharmaceutical. The US alone is the world’s largest and it represents 45 percent of the global market for pharmaceuticals.

The North American pharmaceutical market is the largest in the world.

Not only is it the largest pharmaceutical market, many of the top pharmaceutical companies in the world are in the US. So it is no mystery why gaining FDA approval after obtaining a new drug patent is the brass ring for pharmaceutical companies. With FDA approval offering access to nearly half the world’s market for drugs, being granted FDA approval for a new product is a necessary (but not always sufficient) requirement for success.

However, drug manufacturers also focus on other goals, because pharma is, after all, a global market, and getting a drug approved for sale in the EU, for example, opens the door to global success. Here are some of the other goals, besides FDA approval, that pharmaceutical companies aim for in their plan for long-term success.

European Medicines Agency Committee for Medicinal Products for Human Use Approval

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) plays a key role in the authorization of medicines for sale in the EU. Specifically, the CHMP:

  • Conducts initial assessment of EU marketing authorization applications
  • Assesses modifications to existing EU marketing authorizations
  • Considers recommendations from the agency’s Pharmacovigilance Risk Assessment Committee on medicine safety, and can recommend changes to a medicine’s marketing authorization, including market suspension or withdrawal

The CHMP’s assessments, like those of the FDA, are based on scientific data evaluation to determine whether the medicine meets quality, safety, and efficacy requirements and has a positive balance of benefits compared to risks. Approval by the EMA CHMP essentially opens up the European market to a new medicine.

Approval of Investigational New Drug Applications

Sometimes sponsors of investigational drugs need to ship these early-pipeline products across state lines, such as when a product is shipped to clinical investigators in different states. Normally, drugs must have an FDA-approved marketing application before being transported across state lines, but the Investigational New Drug (IND) application allows an exception to be made for investigational drugs.

Preclinical development requires that drug makers determine the safety of their new product in humans, after having screened the new molecule’s safety and potential toxicity in animals. It is at this point that the molecule’s legal status changes and that IND approval is required for further drug development.

The IND process allows shipment of investigational drugs across state lines.

After submitting an IND, a drug maker must wait 30 days before initiating clinical trials. During that time, the FDA reviews the IND and can step in if there are questions about the product’s safety. IND approval is an important step on the way to clinical trials and full FDA approval.

Clinical Trial Approval

Once the IND process is complete, drug developers must design clinical trials that follow a prescribed protocol. They must determine:

  • Who is qualified to participate in clinical trials
  • How many people will participate
  • How long the study lasts
  • Presence or absence of a control group or other ways to minimize research bias
  • How the drug will be administered and at what dosage
  • Assessments to be done, as well as when and what specific data will be collected
  • How data will be analyzed and reviewed

Phase 1 clinical trials are small, covering 20 to 100 participants. Around 70 percent of drugs move on to Phase 2 trials, which may have several hundred participants and last up to two years. About one-third of these drugs move on to Phase 3 trials, which can have up to 3,000 participants and last for up to four years. Phase 3 trials study drug efficacy and monitoring for adverse reactions. Phase 4 trials involve several thousand participants who have the disease or condition being studied. To file a marketing application for approval by the FDA, a drug developer must have sufficient data from two large, controlled clinical trials.

The drug patent process is long and expensive, and high drug prices reflect the costs of bringing a new product from the lab to the pharmacy. While FDA approval is the main goal of American pharmaceutical developers, there are many steps along the way. Furthermore, European approval is an additional goal that can influence pharmaceutical companies’ plans for drug patents. Understanding the steps in FDA approval, including IND applications and clinical trials, as well as requirements for EU approval, can assist pharmaceutical investors as they monitor the progress of new products.

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