BOGOTA, Colombia – Proposed regulations in Colombia that would eliminate the need for trials for some biotech products have drawn heat from multinational companies and regulators abroad.

Colombia Minister of Health Alejandro Gaviria announced plans to update biotechnology regulations in upcoming weeks. A draft of the proposed changes has been circulated to local industry groups, multinational companies and various regulatory agencies and has created heated debate and some opposition from authorities in the U.S.

The FDA stepped into the debate after receiving the fifth version of the draft changes.

In a letter to Colombia´s Ministry of Health, the FDA openly criticized the Colombian government for the way it is conceiving the regulatory framework for the country's biotech industry. The FDA's biggest problem is the creation of an abbreviated pathway for approvals that would skip requirements for preclinical trials or clinical trials for derived biotech products or for products that contain active ingredients and molecules that have already been tested.

"The abbreviated pathway can be used when it is possible to characterize a molecule and no pre-trials or trials are needed. It is not needed to raise an access barrier of $50 [million] or $100 million that would impede competence," said Gaviria, during a press conference earlier this month as part of the XI International Congress of Hospitals and Clinics in Bogota. "The quality, safety and efficiency matters are not at stake. Having cheaper [products] doesn't mean that we will have lesser quality ones."

Gaviria pointed out that some of the most important biotech patents are set to expire in 2015, 2016 and 2017.

But the FDA worries that abbreviated approval pathway could have a direct impact on safety.

"The draft decree only refers to clinical trial data being necessary to prove the immunogenicity of the active pharmaceutical ingredient. [The] FDA firmly believes that both the drug substance and drug product should be adequately evaluated through the documented methodology to ensure the entire medication's immunogenicity," the agency said in comments in early August.

Other groups have also expressed concerns.

The Association of Pharmaceutical Laboratories of Investigation and Development (Afidro in Spanish), which groups foreign pharmaceutical companies, has been lobbying against the changes.

The guild even launched three Twitter hashtags against the proposal, stating it wanted to warn the public of the risks associated with opening the path to biotech products without trials.

But not all are against the proposal. Backing the changes is the Association of Colombian Pharmaceutical Industries (Asinfar in Spanish).

"That's a fallacy. It is a libelous refrain against the minister himself and against the government," Alberto Bravo, president of Asinfar, said of the opposition. "I've told them that they haven´t stop reviling and slandering when they say that this legislation will leave a trail of dead."

Afidro did not respond to Bioworld´s requests for comment, but its president, Francisco de Paula Gómez, has publicly stated that it is risky to open a door to products may have, in some case, been rejected abroad but could easily be approved for use in Colombia under the new rules.

A 'PURELY COMMERCIAL' DEBATE?

For its part, the Colombian Ministry of Health has pointed to a need for competition to boost the country's health care system.

"At the end, worries from Afidro are commercial worries disguised behind patient safety, and we will not compromise the safety of the patients, but we need to have competition for the moment when patents expire in the biotech sector," said Minister Gaviria. "Basically, what is at stake, is our health system's financial viability and we need to be responsible with this."

Asinfar's Bravo told Bioworld Today that the new draft regulations include some extreme requirements and that the only licenses that would be granted under the abbreviated pathway would be for products that are well known.

"The local pharma industry doesn't want to stay behind countries like Argentina, Brazil, Mexico, Chile and even Peru and some other countries of the region that already have a regulation [for biotech products]," Bravo said. "The regulatory subject is over for us. In this moment what continues is a purely commercial debate, and the magic phrase is that [Afidro] doesn't want a market competition."

But the FDA fears a bio-limbo, under which the terms of reference of the new regulations are vague.

"It is unclear if this abbreviated pathway is intended to describe the approval of a product based on comparison to a reference standard, rather than a reference product. If that is the intent, it is unclear what the scientific standard is when compared to a reference standard, or what the scientific standard of the reference standard is. . . . It is unlikely that a pharmacopeia monograph or reference standard will be sufficiently extensive enough to cover all aspects of characterization, testing, release and stability," said the FDA in its comments.

And its warnings go even further.

"[The] FDA is concerned that while this draft better defines the necessary documentation that an applicant would need to use in order to apply under the abbreviated pathway, it is still unclear how the safety, purity and potency of products in this pathway would be assured," the FDA said. "Of note, the European Medicines Agency (EMA) and FDA do not have such a pathway. Additionally, in the U.S. a sponsor must demonstrate that they are biosimilar to a licensed product, not similar to a monograph."

There are almost 1,700 biotech products in Colombia's $4.2 billion pharmaceutical market. Biotech products make up between 10 percent and 15 percent of the market.

"The country can't afford [a] lack of competitors in that market," Gaviria said.