Generic Line

ORLANDO — Generic-drug makers need to correct manufacturing quality issues that are the main culprit behind drug shortages or face eroding consumer confidence in their copycat drugs, FDA Commissioner Margaret Hamburg says.

ORLANDO — Drugmakers are decrying the lack of a clear, accessible path for achieving interchangeability for biosimilars in a recent FDA guidance, saying the designation is critical for the consumer savings that follow-on biologics promise.

Despite analyst doubts, Mylan is confident it can launch a generic version of Teva’s blockbuster multiple sclerosis (MS) treatment Copaxone in the second half of 2013 pending FDA approval and resolution of legal challenges.

Drugmakers should voluntarily notify the FDA of product quality problems, manufacturing interruptions and delays in acquiring raw materials to help prevent drug shortages, the agency says in draft guidance issued Feb. 14.

While a company-imposed quality control overhaul at Hospira’s Rocky Mount, N.C., facility has assembly lines humming again, production at the plant is not expected to reach full capacity in the near-term and shortages of numerous injectable drugs are likely to continue, Hospira says.

While the FDA stayed true to its previous advice in the three draft biosimilars guidances released earlier this month, experts appear in conflict over how “abbreviated” the approval pathway is.

ORLANDO — Watson Pharmaceuticals CEO Paul Bisaro criticized the FDA for a lack of communication with drugmakers before taking regulatory action that could cause a drug shortage.

The Office of Generic Drugs is slated to receive $53 million in funding in fiscal 2013 under President Barack Obama’s request, a slight decrease from the $56 million the office got this year.

Three months after the FDA flagged three manufacturing plants operated by Sandoz for quality control issues, the Novartis subsidiary has temporarily suspended generic-drug production and discontinued some products at its Boucherville, Quebec, facility to address the agency’s concerns.

American Regent is investigating the root cause behind particles in some retain samples of phenylephrine HCl injection, which prompted a voluntary recall of one product lot.

The FDA and HHS have done all they can administratively to curb drug shortages and now need additional help from Congress, HHS Secretary Kathleen Sebelius told lawmakers Feb. 15.

The brand- and generic-drug industries long have been familiar with citizens petitions. Brand drugmakers often use them to delay generic competition. But generic-drug makers can use the FDA’s petition process to their advantage, an industry attorney says.

The FDA has informed Impax Laboratories it is satisfied with the company’s efforts to address manufacturing violations at its Hayward, Calif., facility, but the agency has not closed out on the matter because a final, required re-inspection of the plant has yet to occur, Impax says.

ORLANDO — With several blockbuster drugs just off or about to come off patent, generic drug substitution will pass 80 percent for the first time in 2012, industry analyst IMS Health says.